What are your thoughts on the recent launch of Renflexis in the United States?

I think that it will be very interesting to see what happens now that we have 3 versions of infliximab on the market. Will this drive the cost down? I think that it remains to be seen. I think, as you look at what has happened since the first biosimilar for infliximab has hit the market, you have seen insurance companies—United, for example, actually signed a contract with Remicade to stay with the bio-originator. I think you are going to see some of this, but I think it will be interesting to see the uptake and how this happens, and I think we will start to see the outcomes of this moving forward.

Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States. 

Dr Marcus H. Snow: The US Launch of Renflexis

Marcus H. Snow, MD

Sandoz said Tuesday the the FDA approved its citrate-free, high-concentration formulation (HCF) of its adalimumab biosimilar, Hyrimoz.

The adalimumab-adaz injection (100 mg/mL) is approved to treat 7 indications covered by the reference product, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” Keren Haruvi, president, Sandoz Inc., head of North America, 

Sandoz set a launch date of July 1 for both versions of Hyrimoz.

The FDA approval was based on a phase 1 pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free, HCF 100 mg/mL. This study met all of the primary objectives, demonstrating comparable PK and showing similar safety and immunogenicity of the low-concentration adalimumab and the HCF adalimumab.

The original, low-concentration version of Hyrimoz was approved by the FDA in 2018. Another HCF version, Hadlima, from Organon and Samsung Bioepis, was approved in August 2022. Biologics license applications for Alvotech and Celltrion Healthcare's high-concentration adalimumab biosimilars are currently under review with the FDA.

In 2023, up to 10 adalimumab biosimilars will enter the market. The first, Amgen’s Amjevita, launched at the 

; as with Hyrimoz, the others are scheduled to launch starting in July 2023.

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).


FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz

Allison Inserro

Celltrion presented data at the American College of Rheumatology (ACR) meeting on November 14, demonstrating that its product CT-P10 is as safe and effective as Rituxan for the treatment of rheumatoid arthritis (RA).

, investigators tested CT-P10 against both US- and EU-licensed versions of rituximab. The study evaluated pharmacokinetic and pharmacodynamics, as well as safety.

Three hundred seventy-two patients participated in the study. A total of 161 were given CT-P10 and the remainder were given the originator product.

The investigators concluded that the pharmacokinetics of CT-P10 were highly similar to those for the originator products (90% confidence intervals were within the equivalence range of 80% to 125%), and the safety profile was noninferior. Infusion-related reactions occurred in 6 (9.4%) of patients in the biosimilar group, 4 (6.2%) in the US-licensed version of rituximab, and 12 (20%) in the EU-licensed group, and all of these reactions were either grade 1 or 2. Discontinuations as a result of an adverse event occurred in 3.1%, 4.6%, and 1.7% of patients taking the biosimilar, US version, and EU version, respectively.

 at the American College of Rheumatology meeting,  a team of researchers sought to gather efficacy data on the biosimilar versus the two licensed versions of Rituxan, using the DAS28-CRP/ESR as a primary endpoint.They found in this phase 3, controlled study, that the biosimilar was therapeutically equivalent to the other treatment groups, with a change in DAS28-CRP of -2.14 for the biosimilar vs. -2.09 for the originator products. Additionally, the change in DAS28-ESR scores were -2.41 vs. -2.35, respectively. ACR 20, 50, and 70 scores were equivalent as well. No significant differences in adverse events were detected among the groups, and no serious complications were reported.

Biosimilar rituximab is being tested not only in patients with RA but in those with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and polyangiitis. If it is approved for treatment, Celltrion’s product would likely be the first CD20-inhibiting monoclonal antibody to reach the market in a biosimilar version.

Celltrion announced that on November 17, 

 for use in South Korea for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. It will be marketed under the name Truxima in that country.

Pharmacokinetics of CT-P10 were highly similar to originator products. 

Ritumixab Biosimilar Demonstrates Positive Results in Rheumatoid Arthritis

Stanton R. Mehr

All eyes in the world of biologics and biosimilars are on the Supreme Court as it decides a constitutional challenge to the Affordable Care Act (ACA) in 

 provisions of the ACA, at stake is the future of the Biologics Price Competition and Innovation Act (BPCIA), which was signed into law on March 23, 2010 as Title VII to the ACA and provides a pathway to market for biosimilar products. For biologic and biosimilar stakeholders, the focus is on whether the Supreme Court will let the BPCIA stand even if it finds provisions of the ACA to be unconstitutional.

The Constitutional Challenge: Can Congress Require a Tax of Zero Dollars?

The ACA was intended to lower insurance premiums and overall health care costs by broadening the insurance pool with the individual mandate, which required individuals to maintain insurance coverage or pay the Internal Revenue Service a “shared responsibility payment.”

National Federation of Independent Business 

, the Supreme Court in 2012 upheld the ACA’s individual mandate under the taxing power of Congress. But in 2017, Congress amended the ACA to set the shared responsibility payment to $0. A number of states and private citizens sued. They argued that the now nonexistent shared responsibility payment cannot be a constitutional exercise of Congress’s power to tax. But that is not the end of the line for the BPCIA. If the individual mandate is unconstitutional, the Supreme Court will have to decide whether it can be “severed” from the rest of the ACA, allowing other provisions of the ACA, including the BPCIA, to remain in place.

Severability, a doctrine that goes back at least to Chief Justice John Marshal in the early 1800s, allows a court to save statutes with unconstitutional provisions by cutting out the invalid part of the law. The basic question is whether Congress would have intended the entire statute to remain without the unconstitutional provision. During Justice Amy Coney Barrett’s recent confirmation hearing, she explained that severability is like a game of judicial Jenga. Once a court identifies an unconstitutional provision, the court must pull out that unconstitutional block. But if the statutory “tower” cannot stand without that block, then the court cannot use severability to save the remainder of the statute.

Many conservative justices have questioned how the severability doctrine can be applied to the ACA. The late Justice Scalia is one example. In a dissent in the NFIB case, he stated that the ACA was not severable, comparing the ACA to a Christmas tree with each member of Congress adding ornaments, making it impossible to discern what should remain if the tree were taken away.

Oral Argument: Playing “Gotcha” With the BPCIA?

There was almost no mention of the BPCIA during the Supreme Court’s oral argument Tuesday in 

. Counsel for the state of California did raise, however, the biosimilar provision in passing as one provision in the statute on which the public relies. Although not the focus of the argument, that reference will not go unnoticed, especially in light of an amicus brief focused directly on the severability of the BPCIA filed by the Association for Accessible Medicines.

Justice Barrett did not show her cards during oral argument. She had, however, stated during her confirmation hearing that she held in a moot (simulated) court competition for law students that the individual mandate could be severed from the ACA. Although a moot court judge’s hypothetical ruling in an academic exercise is not a good basis to predict how she will rule in the actual case, 2 of the conservative-leaning justices made strong statements Tuesday about severability during oral argument.

Chief Justice John Roberts asked whether Congress would “want the rest of the law to survive if the unconstitutional provision were severed.” The chief justice said that there was “compelling evidence on the question,” namely that in 2017 when Congress set the shared responsibility payment to $0, “Congress left the rest of the law intact.”

Justice Brett Kavanaugh also seemed inclined to sever the individual mandate. In an earlier case, he, wrote “Constitutional litigation is not a game of gotcha against Congress, where litigants can ride a discrete constitutional flaw in a statute to take down the whole, otherwise constitutional statute.”

 During the argument by counsel for the House of Representatives, who echoed that thinking, Justice Kavanaugh stated that the severability question was “very straightforward under [Supreme Court] precedents, meaning that we would excise the mandate and leave the rest…in place.”

If Chief Justice Roberts and Justice Kavanaugh side with Justices Stephen Breyer, Sonia Sotomayor, and Elena Kagan, who are widely expected to vote for severability if the court says that the ACA is unconstitutional, then the BPCIA could survive this latest challenge to the ACA. After oral argument, the initial consensus has been that severability is likely if the court holds the individual mandate of the ACA unconstitutional. But as veteran court watchers know, it is not unheard of for the justices to make statements in favor of a position only to vote against it later. Biosimilar manufacturers should continue to advance contingency plans for a post-BPCIA world, just in case the Supreme Court yells “Jenga!”

1. Barr v Am. Ass’n of Political Consultants, Inc

Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).

Legal Opinion: BPCIA Is Likely to Survive Latest ACA Challenge

Chad Landmon is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the firm’s Intellectual Property and FDA Practice Groups. He focuses his practice on patent litigation and counseling and food and drug law, with an emphasis on pharmaceuticals, biologics, medical devices, regenerative medicine, and human tissue products.

Chad Landmon, JD

In the 10 years since the passing of the Biologics Price Competition and Innovation Act (BPCIA), the field of biosimilar legislation and litigation has rapidly expanded, creating a new, complex legal environment. To help navigate the expanding biosimilar legal space, Goodwin law released the 

Guide to Biosimilars Litigation and Regulation in the U.S.

 which provides a guide to each section of the BPA. Goodwin partners Robert Cerwinski, JD, and Alexandra Valenti, JD, discussed the guide on a recent 

“The guide covers all legal and regulatory issues that we've either already seen litigated or expect to see litigated in the coming years that relate to biosimilar products,” Valenti said. The publication is meant as both a guide for those who work closely with biosimilars and biosimilar litigation as well as for those who are new to the space. 

Valenti noted that since the passage of the BPCIA, the Supreme Court, in 

, resolved the issue as to whether a private party had the ability to enforce the act's provisions that pertain to the prelitigation information exchange, or patent dance. "That decision also held that notice of commercial marketing under the statute could be given at any time by the biosimilar, that the biosimilar didn't need to wait for product approval to provide notice of commercial marketing," she said.

One possible issue that is being watched is to see if product liability claims arise in biosimilars. “The interesting thing that we’ll be watching in that space is whether federal preemption principles that have been held to shield generic small molecule drug manufacturers from certain types of product liability claims will also apply in the biosimilar context,” Valenti said.

Anotjher issue to watch is the streamlining of patent issues by district judges, said Cerwinski. A judge may attempt to manage the process in such a way that might be considered more timely and efficient, but this is raising concerns by branded manufacturers.

“Brands have really been concerned about this as a streamlining by district court judges on the ground that not permitting a brand or a patentee to assert whatever patents the [Patent Trade Office] PTO has issued it is unconstitutional,” Cerwinski said. “And is somehow taking a property right or preventing them from exercising them property right? And we expect to see that actually appealed all the way up to the Supreme Court at some point.”

To learn more about the Guide to Biosimilars Litigation and Regulation in the US, visit the purchase page 

What is ahead for biosimilar litigation? We highlight a recent interview Goodwin partners gave recently about their new guide to biosimilar litigation. 

What's Ahead for Biosimilar Litigation?

Sara Karlovitch

As the coronavirus disease 2019 (COVID-19) pandemic spreads, it will continue to affect the biopharmaceutical industry. Biosimilars are no exception, and the effect on their uptake and adoption will be multifaceted. Here are several ways that biosimilars are most likely to be influenced by COVID-19:

Inaccessibility of healthcare providers (HCPs) and other medical decision-makers:

 currently, COVID-19 is setting the priorities for most HCPs and hospital decision-makers: take care of affected patients, navigate the evolving COVID-19 coverage and payment landscape, and maintain an adequate supply of beds and personal protective equipment. During this time, institutions may lack the bandwidth to continue to evaluate complex biosimilar-related decisions and may stick to the status quo, the reference product, or the existing preferred biosimilar product until the dust settles. This will slow down biosimilar uptake across the board. As providers defer to their status quo therapy options to avoid unnecessary disruption, uptake of the 8 therapeutic oncology biosimilars 

 in the United States so far may be particularly hard hit.

Repurposed contracting and promotional activities: 

although many regular account manager activities have been disrupted by social distancing measures, contracting can be conducted effectively via digital media. This is especially true for biosimilar manufacturers with existing relationships or customers interested in immediate cost-saving opportunities who are not yet preoccupied with managing COVID-19. Many financial decision-makers (pharmacy directors, medical directors) are postponing contracting discussions. Account managers can now focus on bringing accounts on board for biosimilars and leave “pull-through” sales activity for later. Also, manufacturers that are preparing to launch biosimilars during this quarter or the next may decide to postpone marketing or do a soft launch, which would entail supplying product, leveraging digital or nonpersonal channels, and contracting via tele-detailing. This could affect biosimilars such as Merck's trastuzumab and bevacizumab biosimilars, Ontruzant and SB8, respectively, which are lined up for launch over the next 2 quarters.

COVID-19 is causing a dramatic mismatch of supply and demand that manufacturers are struggling to forecast. On the supply side, manufacturing and supply chain processes in hubs such as China, India, and the United States are being disrupted due to global lockdowns. On the demand side, conflated factors make demand difficult to predict. On one hand, patients delay seeking treatment, particularly for less convenient administration methods such as infusions, which can lead to lower patient volume and overall demand. On the other hand, stockpiling and demand for subcutaneous or oral formulations may cause a spike in demand for certain products despite decreasing patient volume. In February 2020, the FDA 

 the first case of a shortage of a drug due to coronavirus. Although all manufacturers are working to mitigate the risk of supply shortages, biosimilar manufacturers that rely on facilities in Europe and Asia may be particularly at risk on the supply side (

Delays in biosimilar approvals and clinical trials: 

most clinical trials are likely to be delayed due to challenges managing protocols, deprioritization in favor of more immediate acute care needs, and patients’ inability to travel to appointments. Beyond the logistics and prioritization challenges, manufacturers run the risk of trial participants contracting the disease, which leads to 

 on how to manage clinical trials during the pandemic. All of the above-mentioned complicating factors are likely to undermine Prescription Drug User Fee Act/Biosimilar User Fee Amendments dates for biosimilars with approval decisions scheduled by the end of 2020 (

Increased budget pressure can accelerate postcrisis biosimilar usage: 

Without a doubt, the current situation is putting significant budget pressure on the health system, with many providers 

 copays, coinsurances, and out-of-pocket costs due to COVID-19. Although the broader impact on the economy and health system is still unclear, what is certain is that after the crisis, providers will actively look for ways to compensate for the extra expense they are incurring now, and it will be more important than ever for biosimilars to deliver on their promise to bring savings to the healthcare system. In the meantime, it will be important to monitor what manufacturers of reference products and biosimilars do to help support providers as this situation evolves.

There are additional aspects of the pandemic that will affect both biosimilars and reference products alike, such as ensuring safe supplies of medicine in patients’ homes as we all observe social distancing. Patients, either on their own or in consultation with their HCPs, may start to make adjustments to treatment regimens to allow for less time in the hospital or the clinic, especially when it comes to biologics that suppress their immunity, as also recommended by 

Such recommendations, along with the already limited infrastructure, overburdened healthcare system, and social distancing policies will create a very difficult environment for biologics and biosimilars businesses in the short and medium term. However, companies can think strategically about how to create opportunities from these difficult circumstances, such as leveraging virtual technology for contracting discussions, stressing cost savings with cash-strapped customers, and improving patient-support wraparound services. These will help them set the stage for success in a post—COVID-19 world.

At the end of the day, the priority for everyone right now is protecting health and safety. Although biosimilar adoption and evolution to new treatment paradigms may stall, we firmly believe that health and safety are foremost in mind for providers everywhere.

Christina Corridon, MPH, MBA, is a principal in ZS’s Boston office and leads the firm’s biosimilar vertical. Scott Kniaz, MBA, is a strategy insights and planning manager in ZS’s Washington, DC, office. Will Gatziolis, MBA, is an associate principal in ZS’s New York office. Ross Shahinian is a strategy insights and planning manager in ZS’s New York office. Sandeep Sangwan, MPharm, is a knowledge management consultant in ZS’s New Delhi office.  All are key leaders in the ZS biosimilar vertical.

The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
 

COVID-19's Multifaceted Effect on Biosimilars

Christina Corridon, MPH, MBA

As one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilar industry is clear: nomenclature is critical for identification purposes.

The World Health Organization (WHO) has proposed a “biological qualifier” for tracking biologic products to institute a global approach for patient safety and traceability. As the WHO explains in its proposal, the naming approach “is designed to provide a uniform global means of identification to avoid the proliferation of differing national schemes” — meaning a unified naming system.

But not all stakeholders agree this is the most effective way to move forward.

In 2015, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation & Research and Dr. Karen Midthun, Director of FDA’s Center for Biologics Evaluation and Research, proposed a draft guidance requesting reference products and biosimilars have nonproprietary names (proper names) that share a core drug substance name and for each product, a unique FDA-designated suffix composed of four lowercase letters. For interchangeable biological products, public feedback about whether the nonproprietary name for a product should include a distinct suffix, or share the same suffix as its reference product.

The proposed naming convention seeks to address two main issues: To help prevent accidental substitution of biological products that are not determined to be interchangeable by the FDA, which could lead to medical error; and to support safety monitoring of all biological products after they are on the market with more accurate tracking of the usage of biological products in multiple care settings: outpatient, hospital, and pharmacy.

The FDA’s draft guidance on naming, according to the FTC, could “

result in physicians incorrectly believing

 that biosimilars' drug substances differ in clinically meaningful ways from their reference biologics' drug substances.” The FTC suggested the FDA's proposal would inhibit competition intended to lower prices on biologic medications; many are the most expensive types of drugs in the marketplace. 

The suggestion was that the FDA could track drugs by their brand or trade name instead of a new nonproprietary naming system. The FTC’s rationale is to employ a post-market tracking system and minimize mistakes made when entering information, such as the wrong suffix for a specific drug. 

 along with the Hematology/Oncology Pharmacy Association, among pharmacist members, where it offered insight into how the profession feels about naming conventions for biosimilars. Among 781 poll-takers, the clear favorite was the nonproprietary proper name with a designated suffix. However, when asked about their level of confidence when dispensing a biosimilar instead of the reference biologic, pharmacists were more sure when the products had the same nonproprietary name in common.

The poll also probed attitudes regarding regulations requiring pharmacists to submit postdispense notifications. The results suggest the obligations placed on pharmacists could deter some from dispensing interchangeable biologics, although this hesitance would be mitigated if the biologics were to share the same nonproprietary name as the reference biologic.

Amgen’s executive director of global operations, Gino Grampp, says his company supports policies that ensure biologicals, both originators and biosimilars are prescribed, dispensed and monitored appropriately. “We are very concerned about a tendency to move towards International nonproprietary names (INN)-based prescribing and dispensing by INN, and towards INNs being used in adverse event reports” for biologicals. Grampp also said that clear identification and traceability was “a good way of achieving this. So we support measures to promote product- specific traceability in health records and pharmacovigilance reports, and we believe that identifiers like the BQ or the (US) FDA’s four-letter suffix will help.”

The European Biosimilars Group (EBG), part of the European Generic and Biosimilar Medicines Association, openly challenged the proposed biosimilars naming convention in a policy document presented at the WHO consultation meeting in April 2015, “The current system works well; the introduction of a special system for a specific class of products disrupts this well-working unified system,” said the EBG. “Physicians and pharmacists will be confused as to what to do with the new, unknown identifier. This increases the risk of prescription errors, dispensing errors, medication errors and adverse reaction reporting errors.” The 

 can only increase the risk of error or hinder pharmacovigilance.

The US Generic Pharmaceutical Association (GPhA) is also not clear why the addition of a BQ to the INN would provide any additional value as it thinks the current INN naming system is simple and should not be changed, according to a WHO document published in March 2015. The GPhA also thinks the proposed BQ scheme should not have a manufacturing site designation, but if a modifier is to be used, the clearest format would be the marketing authorization holders’ (MAH’s) name.

For nearly a decade, BIO has advocated actively for a nonproprietary naming convention that ensures all biological products are distinguishable, and believes that a distinguishable nonproprietary naming convention would best facilitate pharmacovigilance, ensure accurate attribution of adverse events to the correct product, prevent inappropriate substitution and unintended switching, and support tracing of products in the event of a recall. In short, BIO strongly believes that distinguishable nonproprietary names enhance patient safety.

A date has not yet been set for the FDA’s formal ruling on biosimilar naming conventions in the US—but clearly the debate will continue among the key industry stakeholders until the decision is finalized.

As one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilars industry is clear: nomenclature is critical for identification purposes.

Naming Biosimilars: The Debate Rages On

Daniella Latham

A phase 1 equivalence study of ABP-215 (Mvasi, the first FDA-approved biosimilar bevacizumab) concludes that ABP-215 demonstrated pharmacokinetic (PK) similarity to the reference drug in healthy Japanese men.

 is an inhibitor of blood vessel growth and is 

 in the United States for chemotherapy and targeted therapy for colorectal, lung, glioblastoma, kidney, and cervical cancer. 

Safety profiles were comparable between subjects dosed with the reference and the biosimilar, and PK data in Japanese subjects were consistent with those previously shown in global studies. 

 by Vladimir Hanes, MD, and colleagues in 

The randomized, single-blind, single-dose, parallel-group study had as its primary endpoints maximum observed serum concentration (C

) and area under the serum concentration—time curve from time 0 to infinity (AUC

). Secondary endpoints included AUC from time 0 to time of last quantifiable concentration (AUC

), safety, tolerability, and immunogenicity. The study lasted 57 days. 

Each of the 2 study groups had 24 subjects; all had similar baseline characteristics and were between 18 and 45 years of age. All 48 study subjects completed the infusion; 46 completed the study because 2 were lost to follow-up. 

After a 3-mg/kg IV infusion, the geometric means (GM) of C

were71.2 μg/mL, 25,259 μg h/mL, and 22,499.3 μg h/mL, respectively, for ABP-215 and 70.16 μg/mL, 25,801 μg h/mL, and 22,604.6 μg h/mL, respectively, for bevacizumab. The GM ratios (90% CI) for C

were 1.015 (0.946-1.088), 0.979 (0.914-1.049), and 0.995 (0.941-1.053) for ABP-215 versus bevacizumab. All confidence intervals were within the prespecified bioequivalence margin of 0.80-1.25. 

Adverse events (AEs) occurred in 2 of 24 subjects receiving ABP-215 and 1 of 24 receiving reference drug. No subject experienced an infusion reaction or hypersensitivity AE in the first 2 days after study drug administration. There were no deaths or AEs leading to discontinuation, and no patient was positive for binding anti-drug antibodies. 

The researchers concluded that their data were consistent with the PK equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan. 

Hanes V, Chow V, Pan Z, Markus R. A randomized, single-blind, single-dose study to assess the pharmacokinetic equivalence of the biosimilar ABP 215 and bevacizumab in healthy Japanese male subjects. 

2018;82:899-905. doi: 10.1007/s00280-018-3695-4.

The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan. 

Study Finds ABP 215 and Bevacizumab Demonstrate PK Similarity in Japanese Men

Jackie Syrop

Nicola Davies, PhD, has a background in health psychology and over a decade of experience in medical writing. In addition to writing both US and EU regulatory columns, she has produced many large industry reports for the pharmaceutical industry. Topics she has covered range from orphan drugs to biosimilars, digital health, clinical trials, medical affairs, and payer perceptions, among many others. She also produces independent medical education for healthcare providers wishing to develop their knowledge of the pharmaceutical landscape.

Nicola Davies, PhD

Unlike flu epidemics, which are regional, the coronavirus disease 2019 (COVID-19) is a pandemic that crosses international boundaries and affects a very large number of people. While many companies are in lockdown, pharmaceutical companies are identifying methods of ensuring supply continuity so that patients taking regular medication can continue to receive the treatments they need. Without the maintenance of medicine supply chains, lifesaving medicines could become unavailable, with the health of many unwell people being compromised.

Some European Union (EU) member states have indicated that they expect shortages to occur soon or are starting to experience shortages of certain medicines being used to treat patients with 

. In April 2020, the European Medicines Agency organized the first meeting of the EU Executive Steering Group to address the impact of COVID-19 on the supply of medicines in Europe. The group aims to supply strategic leadership for urgent action and will identify and coordinate EU-wide actions to protect patients who may be affected. The FDA is working closely with manufacturers to mitigate shortages and has recommended that, should the need arise, alternative medications be used by patients.

Samsung Bioepis is a biopharmaceutical company that supplies medicines to many countries around the world. COVID-19 affects our business, as it does many others in the pharma industry. Six months ago, there were about 100,000 planes flying globally every day. Now, there are fewer than 60,000 

 each day, and many flights are cancelled or delayed depending on infection rates in different regions. Our freights are examined and re-examined according to newly implemented processes due to COVID-19, adding additional transit days to already lengthened supply chain lead-times; and our raw material suppliers and manufacturing partners are working nonstop to support our strained supply chain with limited resources and limited capacities. We have implemented mitigation plans and changed our working patterns to minimize the impact COVID-19 has on medicine supply.

For Samsung Bioepis, our supply chain is geographically diversified. To ensure supply continuity and flexibility to swiftly respond to market changes, we have regionalized supply chain activities to provide near-market manufacturing. And under the current situation, this has been beneficial for our supply chain. However, based on recent lessons learned about COVID-19 challenges for logistics, we spend more time with our logistics vendors or internally develop freight-routing possibilities to ensure the supply of medicine is not diminished. Based on the latest flight schedules, we review and update, on a weekly or sometimes daily basis, routes, shipping solutions, and modes of transport. We are also working to build and diversify our current modes of transport, shipping solutions, and routes to provide more flexibility when moving our biosimilar products around world during this challenging time. Fortunately, with these reviews and actions put in place, we have not experienced any disruptions to the supply of our biosimilars.

Recently, there has been a debate about whether manufacturing of “critical” prescription drugs should become more US-based to ensure the availability of medicines to patients in the United States. Many times, supply chains are globalized not just because of cost benefits but also due to advancements in technological know-how. Yes, it may be cost-effective to manufacture active pharmaceutical ingredients (APIs) or specific raw materials in certain parts of the world, but these countries may have a technological advantage for making critical APIs and raw materials at a much larger scale for global supply. Therefore, the use of incentives to spur in-country manufacturing of critical APIs and raw materials may not be sustainable in the long run, especially as the critical prescription drug list becomes longer.

Currently, many biopharmaceutical companies are rushing to develop a COVID-19 vaccine. Once a vaccine is developed and approved, what are the next steps to bring production to commercial scale and make this vaccine available to everyone in need?

In a time when the global supply chain is essential, we need to work together to remove the roadblocks to ensure that all “critical drugs” are provided to patients who need them. Globalization of the supply chain provides value for the efficient manufacture and distribution of these critical APIs and raw materials. It takes into consideration the technology and the global resources necessary to do so. By harmonizing these supply efforts and providing guidelines that all countries can follow, these critical APIs and raw materials can be supplied globally during the pandemic, ensuring that medicines are provided to patients in a timely manner. COVID-19 is changing the current supply chain every day and, to ensure critical drugs are provided to patients who desperately need them, industry and regulatory agencies should come together to stabilize a supply chain that is sustainable in the long-run.

Kris Soyoung Lee is the vice president of the Supply Chain Management team at Samsung Bioepis. She has more than 20 years of experience in supply chain management across various industries including chemical, pharmaceutical, and biopharmaceutical.

How Samsung Bioepis Has Restructured Its Supply Chain Amid the Pandemic

Kris Soyoung Lee is the vice president of the Supply Chain Management team at Samsung Bioepis of Incheon, Republic of Korea. She has more than 20 years of experience in supply chain management across various industries, including chemical, pharmaceutical, and biopharmaceutical.

Authors