In March 2021, the National Comprehensive Cancer Network’s (NCCN) Oncology Research Program, in partnership with Pfizer, announced 10 research projects that will receive funding to develop innovative ways to improve biosimilar adoption in the oncology space.

For this Not So Different series, The Center for Biosimilars® is spotlighting 3 projects to improve perception of biosimilars, promote biosimilars as a therapy choice, and encourage payers to prefer biosimilar use.

In this second part, we spoke with Muhammad Shaalan Beg, MD, director of GI Medical Oncology at UT Southwestern Medical Center. Dr Beg discussed how his project titled “Developing a Clinical Decision Support Tool for Biosimilar Use in Oncology” will make it easier for physicians to choose biosimilars for their patients.

To learn more about struggles regarding physician decisions on biosimilars, click 

For more on payer influence on prescribing patterns, click 

For more on NCCN’s biosimilar work, click 

Podcasts

This is the second of a 3-part series on National Comprehensive Cancer Network/Pfizer efforts to investigate issues of importance to biosimilar stakeholders.

Not So Different: What’s Stopping Physicians From Prescribing Biosimilars? 

In March 2021, the National Comprehensive Cancer Network’s (NCCN) Oncology Research Program, in partnership with Pfizer, announced that 10 research projects have been chosen to receive funding to focus on innovative ways to improve biosimilar adoption in the oncology space.

For this 3-part series of Not So Different, The Center for Biosimilars® has chosen projects that relate to improving perception of biosimilars, choice of biosimilars, and payer preferences for biosimilars.

In this first part, we spoke with Claire Saxton, vice president of education at Cancer Support Community, a worldwide patient and family advocacy organization that provides financial support and navigation services. Saxton discussed how her project titled “Frankly Speaking About Cancer: Biosimilars—Researching Oncology Patient and Caregiver Perceptions” will help address the current perception issues surrounding biosimilars.

For more on biosimilar perception, click 

For more on NCCN’s biosimilar work, click 

This is part 1 of a series on National Comprehensive Cancer Network/Pfizer efforts to investigate issues of importance to biosimilar stakeholders. 

Not So Different: How to Improve Perception Hurdles to Biosimilar Adoption 

At the beginning of 2021, the United Kingdom officially parted ways with the European Union in the landmark event known as Brexit. Under Brexit, regulatory reforms have created challenges for pharmaceutical companies, including biosimilar developers, forcing them to restructure their activities to fit the needs of the British government’s policies and ensure that their products could still be marketed in the United Kingdom and across the European Union. The new regulatory independence in the United Kingdom has also created opportunities for innovation and growth.

We spoke with Maria Manley, LLM, a London-based partner with Sidley Austin and an expert on the life sciences, about the pros and cons of Brexit for the UK’s biologics industry.

To learn more about Brexit's impact on the biologics industry, click 

Maria Manley, LLM, a life sciences expert, talks about how the United Kingdom’s exit from the European Union has changed the regulatory landscape for biologics.

Not So Different: Has Brexit Hindered Biosimilar Development?

If you are aware of the placebo effect, you may have heard of its opposite relative, the nocebo effect, where instead of positive thinking leading to an improvement in health, patient fears about drug quality may result in little or no effect from therapy. The nocebo effect is a common concern in the biosimilar space, where patients often doubt whether biosimilars are clinically similar to reference products.

A recent study on the nocebo effect in biosimilar use demonstrated that nurses may be best able to boost patient confidence in biosimilars and improve retention rates. The authors noted that because nurses are usually the first point of contact for patients in the health care system, they can be effective advocates at facilitating switching and biosimilar acceptance.

We sat down with Juliette Petit, MD, a rheumatologist at Saint-Antoine Hospital at Sorbonne University in Paris, France, and one of the study’s co-authors to discuss some of the major points in her study what it could mean for the future of biosimilar uptake.

Juliette Petit, MD, a French rheumatologist, talks about her recent study showing that nurses can help curb patient fears and prevent a possible nocebo effect when switching them to a biosimilar.

Dr Juliette Petit: How Nurses Can Prevent Nocebo Effect in Biosimilar Switching

Recently, legislators in Minnesota introduced a bill that could force health plans and pharmacy benefit managers (PBMs) to provide equal coverage for biosimilars and reference products, removing the ability for plans to prefer higher-cost originators or limited numbers of biosimilars. The bipartisan bill was designed by Representative Jennifer Schultz (D, Duluth) and Senator Carla Nelson (R, Rochester) and was drafted in consultation with research scientists at Essentia Health and the Mayo Clinic.

We spoke with Schultz, who has a PhD in health economics, to discuss why a bill like this is needed in Minnesota and how it can help foster competition in the biologics market.

To read the bill’s official text, click 

To learn more about payer formulary preferences, click 

State Representative Jennifer Schultz (D, Duluth) explains how her bill requiring payers to cover all approved biosimilars and reference products would save money and improve access.

Not So Different: Minnesota Legislator Discusses Bill to Broaden Biosimilar Coverage

Before the battle for market share gets started, the courtroom is the OK Corral for biosimilar developers and reference product manufacturers, who duke it out over patents to determine how soon biosimilars can enter the marketplace. We spoke with Alexandra Valenti, JD, and Rob Cerwinski, JD, Goodwin partners and senior editors of the updated 

Guide to Biosimilars Litigation and Regulation in the US

To learn more about Valenti and Cerwinski's updated guide, click 

To learn more about adalimumab patent disputes, click 

To learn more about the future state for the adalimumab market, click 

Key 2020-2021 updates to the Guide to Biosimilars litigation and Regulation in the US encompass antitrust litigation, preliminary injunctions, and a slowdown in litigation.

Not So Different: Goodwin Attorneys Discuss Updates to Biosimilars Litigation Guide

In 2019, British Columbia (BC) became the first Canadian province to announce and implement a biosimilars switching initiative. Soon after, 3 other provinces developed their own plans to draw on biosimilars for health care savings. BC’s initiative introduced a mandatory switching policy from reference products to a select list of biosimilars. Each phase of the initiative is given a transition period, allowing physicians time to prepare patients for biosimilars before BC PharmaCare, the public health program, officially stops covering the reference products. The province recently concluded in its third phase, officially using etanercept, infliximab, rituximab, and insulin glargine biosimilars as the primary medications to treat a number of rheumatic conditions, such as ankylosing spondylitis and rheumatoid arthritis.

Pacific Blue Cross, one of the health plan providers in BC, has already seen success in aligning plan sponsors and members with the initiative, generating $27 million in savings by converting 99% of their plans. We sat down with Anar Dossa, director of Pharmacy Services at Pacific Blue Cross and leader of biosimilar transitions for the company’s benefits plan clients and members, to discuss company projections and challenges that have come with implementing the initiative.

To learn more about phase 3 of the BC Biosimilars Initiative, click 

To learn more about recent biosimilar launches in Canada, click 

To learn more about biosimilar switches in Canada, click 

To learn more about other Canadian province’s biosimilar plans, click 

To learn more about Pacific Blue Cross’s success with the program, click 

Anar Dossa, director of Pharmacy Services at Pacific Blue Cross, discusses the company's involvement with British Columbia's biosimilars switching program.

Not So Different: Anar Dossa Discusses Success and Savings With British Columbia’s Biosimilars Initiative

Reference adalimumab (Humira), developed by AbbVie was approved by the FDA in December 2002 and quickly became a blockbuster drug used to treat 12 rheumatic and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Biosimilar competition overseas has eroded much of AbbVie’s international market share. Humira’s patent thicket and settlements have shielded the drug from US market competition posed by biosimilars until 2023. Additionally, AbbVie developed and received approval for a high-concentration, citrate-free formulation, which has rapidly become the dominant form of adalimumab, posing an additional challenge to biosimilar competitors.

However, Celltrion Healthcare and Alvotech are positioning themselves to be the leaders in high-concentration, citrate-free adalimumab biosimilars, with Celltrion getting the greenlight Yuflyma in mid-February 2021 from the European Union to enter the market. With new versions of adalimumab on the horizon, what will this mean for the market and the biosimilars already marketed and in the US’ pipeline?

We sat down with Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of Karyo Biologics, Adello Biologics, and PharmSci, to discuss the implications for the adalimumab market and patients.

To learn more about Celltrion's EU approval, click 

To learn more about Alvotech’s high concentration adalimumab, click 

To learn more about high-concentration citrate-free adalimumab products, click 

We sat down with Sarfaraz Niazi, PhD, an adjunct professor and biosimilar industry expert, to discuss the potential impact high-concentration adalimumab products could have on the US market.

Not So Different: Sarfaraz Niazi, PhD Discusses Market Projections For High-Concentration Adalimumab Biosimilars

In late 2020, Boehringer Ingelheim (BI) filed a citizen’s petition requesting the FDA to alter its definition of the word “strength” as used in a section of the Biologics Price Competition and Innovation Act (BPCIA). As of right now, the term is used in regard to parenteral solutions and does not allow a biological product to be licensed as a biosimilar or an interchangeable biosimilar if any variation in the volume of inactive drug content exists, even if the amount of active drug content remains consistent with the reference product.

The company argued that the current definition permits originator manufacturers to continue to develop follow-on products by only slightly changing the formulation in order to prevent biosimilar competitors from obtaining market share and goes against the goals of the BPCIA and the intention of Congress when the BPCIA was passed.

We spoke with Steven Lucio, PharmD, BCPS, vice president of Pharmacy Solutions for Vizient, to discuss his thoughts on BI’s petition and what needs to be done to advance biosimilar uptake in the United States.

To learn more about BI’s citizen petition, click 

To hear more from Steven Lucio, PharmD, BCPS, click 

We sat down with Steven Lucio, PharmD, BCPS, senior principal of Pharmacy Solutions for Vizient, to discuss Boehringer Ingelheim's recent citizen's petition to the FDA. 

Not So Different: Steven Lucio Discusses BI’s Citizen Petition and the Current Status of Biosimilars

The biosimilar market in China has some similarities to the one in the United States. Both countries approved their first biosimilar years after the European Union, have growth that has eclipsed the growth of their respective generic markets, and are actively working make lower cost drugs available. Still, there are some major differences.

First, to get a biosimilar developed and approved takes much longer in the US than in China. According to Huiya Wu, JD, an intellectual property law attorney from Goodwin Procter in New York, biosimilar development alone takes around 7 to 8 years in the US but could take as little as 5 years in China. Costs are vastly different as well. In the US, development can cost between $75 million and $250 million but in China, biosimilar development could cost closer to just $50 million.

Another interesting characteristic of China’s market is the emphasis on small biopharmaceutical companies. For the most part, well-established Big Pharma companies and large international companies, like Celltrion, dominate the US biosimilar market, but are mostly absent in China’s.

This trait also relates to the issue of patent disputes, one of the biggest barriers to biosimilars in the US, where large, prosperous pharmaceutical companies will battle smaller developers in court to prevent competitive biosimilar products from entering the market.

Luckily for China, their intellectual property laws were developed in a way that would actually allow earlier entry of biosimilars. For instance, China had its first adalimumab biosimilar, which was developed by China-based company Bio-Thera Solutions, launch in 2020. Meanwhile in the US, the reference manufacturer, AbbVie, has been able to take advantage of US patent laws to stall adalimumab biosimilar competition there until 2023.

Biosimilar growth in China is projected to greatly eclipse that of the reference drugs at a much faster rate than in the US, largely due to there being greater acceptance of nonreference products, another barrier for the US market. To see just how comfortable China is with nonoriginator products, let’s consider how many biologics they have. The country’s market has amassed 382 biologic drugs and vaccines, but only 21 are originator products.

Currently the US is ahead of China, with 29 biosimilar approvals vs China’s 9, and a biosimilars market worth $737 million vs China’s $354 million, according to Wu. The US market is even expected to stay ahead of China’s through at least 2027. However, there are signs that China has the regulatory infrastructure needed to not only catch up to the US, but surpass it. Already, the country’s biosimilars market is growing at a 25% compound annual growth rate.

One policy China has adopted is that of expanding access to reimbursement by adding many biologics to the national reimbursed drug list in 2017. China also developed a priority review process for drugs, similar to the one in the US, in 2016, helping to greatly shorten application review times.

Both countries are roughly on par when it comes to interchangeability of biosimilars In the US, interchangeability allows pharmacists to give patients a biosimilar instead of a reference product without needing permission from a physician, but at present, there are no interchangeable biosimilars in the US, making it more difficult for patients to have access to biosimilar cost savings. In China there is no interchangeable designation for biosimilars, and biosimilars cannot be automatically substituted for reference products.

Although China still has a long way to go to achieve the size of the US biosimilar market, there is definitely potential for China to expand its biosimilar industry. The country’s culture and regulatory system seem to be able to really drive uptake and approvals going forward. The questions that remain are how big a share of the Chinese biosimilar market will outside companies get, and what role will Chinese biosimilar producers play on the global market?

You can read more about China’s market by clicking 

For information on Bio-Thera Solutions, click 

For information on Shanghai Henlius Biotech, click 

China’s regulatory reforms and policy enhancements bode well for a thriving biosimilars industry.