Maggie L. Shaw

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, explains how oncologists can work with other stakeholders to expand access to biosimilars and how patients can work with providers and biosimilar manufacturers to address financial challenges.

What more needs to be done to ensure that oncology and supportive care biosimilars are affordable and accessible for patients with cancer?

The affordability and accessibility that biosimilars bring to us is something that cannot be understated. I think one of the challenges sometimes is how it relates to the finances of your overall cancer center. Sometimes there's a lot of misinformation out there. Sometimes it's disinformation as well. We have to understand what the finances are around how expensive medications are, what we charge—whether it be the insurance company or Medicare and Medicaid—and then actually understanding how we're reimbursed. What I've been surprised by in my career is that how few people, sometimes in decision making roles, within oncology don't really have a full grasp of how they're actually reimbursed for medications.

I encourage everyone that's out there listening to actually sit down and ask those questions. You know, bring in your revenue cycle management team, bring in your managed care team. Obviously, bring in your pharmacy team, because there's a lot of things at play here. First, you have to understand how much you're paying for the drug and if there are any rebates or any contractual arrangements that are important. Next is how much you're charging for it. But most importantly, it's how much money is actually coming back in.

When you actually sit down and do that analysis, I think most people will find that biosimilars really affords them a much better financial picture than some of the reference products and that's why it's so critical to really understand the financial implications of biosimilars rather than getting caught up in the previous dogma of more expensive drugs means higher margin. That's not always the truth. And biosimilars has really changed the way we have to approach the finances of health care.

But once we do that, then we also have to think about the accessibility aspect. So, depending on patients insurance, a more expensive drugs may, obviously, decrease their ability to have access to that medication. If they have excessive out-of-pocket [costs], where they have to be charged a percentage of the total charges out-of-pocket, some patients start making decisions based on the cost of their therapy, and that's exactly what we don't want to occur.

So, the other aspect that's really great about having biosimilars and having a number of them out in the market is that every single one of them has their own patient assistance program. And so, if there is that question of the affordability or the accessibility of care, the great thing is you can engage those manufacturers, you can understand what their patient assistance programs are, and you can find ways to work with them to ensure patients have access to those critical medications.

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Dr Andre Harvin Answers How Oncologists Can Work to Expand Access to Biosimilars

The prospect for on-body pegfilgrastim biosimilars is one of the most exciting things coming down the pipeline in the supportive cancer space, said Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health.

What are some strategies that clinics and pharmacists can implement to increase biosimilar uptake and realize cost savings?

There are a lot of strategies that clinics and hospitals can utilize for biosimilar uptake. Probably the most important thing is to engage your pharmacy team. As pharmacists, we are your drug experts. We're here for you, we're in your corner, and we really understand the benefits that biosimilars have for not only your clinic, but also your patients as well.

One of the most important things is to start with education. Make sure that everyone on the team understands what a biosimilar is and what it's not. The great thing about them is that the FDA has so many great resources that really lays it out. This is the difference between that and maybe a generic. Are there any issues with things like interchangeability and how you can go about operating those? So, there's a lot of resources there, and there's a ton of publications that have been brought out in the last year that talk about successful programs. And so luckily, you don't have to go at it alone. You just have to make sure that you engage your pharmacy team and really focus on the educational aspect.

Most importantly, you're going to realize a ton of cost savings. That's exactly what biosimilars were brought to the market to do. They were brought in to bend the curve down in terms of our spend in overall oncology care. And the most important thing is that this helps patients and their access to really critical medications. And so, if you're not using biosimilars, I think that's a bigger question of how to best implement them.

How to do you feel about the prospect of more supportive care biosimilars coming to the US market, especially as we move closer to having biosimilar competitors for Neulasta Onpro?

To me, this is one of the most exciting things when I think about the additional competitors that are coming to the market in biosimilar categories, especially when we think about the Onpro device that's been just so dominant in the market for so many years.

This is a patient access issue, right? Some patients don't have that opportunity or it's difficult for them to come back to the clinic multiple days in a row. And that on-body [device], unfortunately, just because of the patents surrounding it, has been able to be dominant in the market and continuously get more and more expensive.

So now that we have new competitors that are coming in the market that are going to have an equivalent device so that patients can receive their Neulasta [pegfilgrastim] on time, safely, without having to return to the clinic is really one of the most exciting prospects I think for the future of oncology care.

We know that when biosimilars come into the market, regardless of the product, they start to drive prices down, and they drive [them] down quickly and significantly. And this is exactly what we need to support as providers, as clinicians, as supportive care services. We need to find ways to make cancer care cheaper, and I can't think of a better opportunity than to have a biosimilar for the on-body [device]. It's going to be a game changer and I'm really excited for it.

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, expressed staunch belief that biosimilars referencing Neulasta Onpro, the on-body injector version of reference pegfilgrastim, are one of the most exciting things coming to the supportive cancer care space.

Dr Andre Harvin Explains His Excitement for Neulasta Onpro Biosimilars

, the website of The American Journal of Managed Care

On the second day of AMCP 2023, Magellan Rx Management  representatives provided a detailed overview of current treatment options in the ophthalmic space and the impact that biosimilars could have, in a session called "Biosimilars in Vision: Addressing Drug Trends and Managed Care Strategies.”

Sneha Sharma, PharmD, and Prerak Parikh, PharmD, both directors of specialty clinical solutions at Magellan Rx, also explored payer management strategies for anti–vascular endothelial growth factor (VEGF) therapeutics—the current standard of care in ophthalmic diseases—the challenges inherent with biosimilar interchangeability status, and the potential cost impact of ophthalmic drugs in the pipeline.

They shaped their discussions around 2 common retinal diseases: age-related macular degeneration (AMD), within which there is dry AMD (geographic atrophy) and wet AMD (wAMD; neovascular or exudative), and diabetic macular edema (DME).

“At present, wAMD accounts for 10% to 15% of AMD cases, but it’s responsible for 90% of severe vision loss, so as we speak to treatment options, we need to remember these are not cures,” she explained. “They are treatment options that are for chronic disease states and there are challenges associated with these treatments, as you’re injecting something into the eye.”

The prevalence of wAMD, Sharma added, is expected to reach the 22 million mark by 2050, with risk factors that include poor diet, smoking history, age older than 50, and hypertension. Current gold standard for first-line therapy for wAMD is VEGF inhibitors, as recommended by the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists. However, treatment-related challenges are ever present, including patient understanding and education on VEGF inhibitors and access andadherence to prescribed therapy.

Currently, 4.2 million individuals living with diabetes have diabetic retinopathy, of which DME is a potential complication. Experts, Sharma noted, expect 6.6% (1 of every 15) of patients to progress to retinopathy. The primary risk factor for DME is a build up of blood sugar. Here, the AAO also recommends VEGF inhibitors for first-line treatment—after bring diabetes under control—and this is commonly initiated in patients who have moderate/severe disease and visual acuity of 20/30 or worse. In addition, patients should be educated on glycemic control and the importance of yearly diabetic eye exams.

There are presently 8 VEGF inhibitors used in the ophthalmic space for AMD and DME:

For both diseases, there are Avastin (bevacizumab), which is used off label; Beovu (brolucizumab-dbll); Lucentis (ranibizumab); Cimerli (ranibizumab-eqrn), biosimilar to Lucentis; Eylea (aflibercept); and Vabysmo (faricimab-avoa).

For AMD only, there is Byooviz (ranibizumab-nuna), another biosimilar to Lucentis, and Susvimo (ranibizumab), which was recalled in October.

For AMD, these medications are administered from every 4 to every 16 weeks, with doses that range from 0.5 to 6.0 mg, and for DME, the dosing periods are every 4 to every 12 weeks, and doses range from 0.3 to 6.0 mg. The most cost-effective is Avastin, with a wholesale acquisition cost (WAC) and an average sales price (ASP) of $849 and $956, respectively, in AMD and DME. In comparison, for AMD, Lucentis has the highest WAC at $24,400 and Eylea has the highest ASP at $14,373, and for DME, Vabysmo has the highest WAC and ASP, at $17,520 and $18,082, respectively.

Looking at the market landscape through 2022 for Magellan, the highest total spend ($111,939,304) and cost/patient ($9092) were seen from Eylea; Avastin had the most patients (22,441) and the most claims (86,449); and Vabysmo had the highest cost/claim ($2971).

In contrast, Vabysmo had the least total spend ($20,795) and the fewest patients and claims (7 each), while Avastin had the lowest costs per patient ($467) and claim ($121).

Again looking at the market landscape, but instead using 2020 data on Medicare Part B spending, Eylea had a total spend of $3.5 billion-plus, with a cost/claim of $2439, and Lucentis had a total spend of $1.1 billion and a cost/claim of $1820. These numbers put these 2 drugs in the second and sixth slots for drug spend overall for 2020.

“I just want to mention here that a higher margin could be offered in the fee schedule for Avastin to help align with the brand name drugs—essentially and enhanced reimbursement,” Sharma noted.

If these treatment trends continue, for AMD, Lucentis will remain in the top slot for annual WAC and Eylea for annual ASP, and for DME, Eylea is tops in both. Looking at claims, according to Magellan data from 2019 to 2022, Avastin claims in the commercial, Medicare, and Medicaid spaces continued to rise steadily, while those for Eylea and Lucentis dropped.

With these numbers in flux, among the utilization management strategies in the ophthalmic space, biosimilars are picking up speed. There are 4 FDA-approved ophthalmic biosimilars, but only 2 are currently being used. Byooviz and Cimerli reference Lucentis and have potential for use as step therapy, but CMS recommends against using Mvasi and Zirabev, because there was not enough data to support their use—they are currently only approved for oncologic use.

Parikh picked up the discussion from here, providing insight and understanding into the ophthalmic biosimilar landscape, both the difficulties inherent in bring these therapeutics to market and the promises they hold in alleviating drug costs and increasing treatment access.

Compared with regular branded medications, which have a 10-step approval process that includes submission of an investigational new drug application, phase 1-3 clinical trials, facility review, and postmarketing surveillance, biosimilars and interchangeable biosimilars have abbreviated drug approval pathways, which makes it easier for them to enter the market, according to Parikh:

Biosimilars: analytical studies > animal studies > clinical studies > comparative clinical studies

Interchangeable biosimilars: analytical studies > animal studies > clinical studies > comparative clinical studies > switching study or additional clinical studies

However, there is a disconnect at the state and federal levels when it comes to getting these medications into the hands of patients. Although the FDA grants interchangeability status on a federal level, substitution and dispensing for pharmacies is determined at the state level, which is where pharmacy laws diverge regarding prescriber notification and permission, patient notification and consent, documentation requirements, and cost.

“All 50 states have some sort of laws regarding the interchangeability of biosimilars, and those laws vary from state to state,” Parikh explained. “So, to put things in perspective, about 40 states require the dispensing pharmacist document and notify the patient about any substitution.”

For example, for automatic substitution, New York allows the practice, North Carolina allows the move only if that drug will reduce patient spend, and Indiana does not allow automatic substitution. In addition, communication on the substitution is required in New York and Indiana but not in North Carolina, and the timelines to notify patients and providers of switching vary from not specified or not applicable to within 5 to 10 days.

“I want to note that even though the interchangeability designation allows for better access to biosimilars, the differences in state regulations still remain a hurdle,” Parikh underscored. “For the dispensing pharmacist at specialty pharmacies who are shipping to different states, they have to be aware of all these different laws.”

Additional difficulties for getting interchangeable biosimilars to market are evident in how they are managed as a pharmacy vs a medical benefit, with key differences evident for automatic substitution, claims adjudication, and preferencing strategy. For example, for automatic substitution, pharmacists have the capacity to switch when allowed by state law, but for medical drugs that may be purchased as buy and bill and are administered in a physician’s office, substitution decisions are often at the mercy of provider preference and product availability.

Further, for claims adjudication, this occurs at the National Drug Code level for the pharmacy benefit and at the Healthcare Common Procedure Coding System level for the medical benefit, and for preferencing strategy, interchangeability designation does not guarantee preferred formulary status, with pharmacy and medical benefit decisions often coming down to WAC and average wholesale price and ASP, respectively.

Within the ophthalmic biosimilar space specifically, there exist the hurdles of provider hesitancy, nonparity with indications, the cost of compounded bevacizumab, and costs of biosimilars vs their reference products. Payer solutions that Parikh proffered include the following:

Automatic authorizations for interchangeable biosimilars that match reference product authorizations

Allow for payment of interchangeable biosimilars at the claims level as long as there is an approved authorization for either product

Provider education for those who express hesitancy

In addition, with compounded bevacizumab continuing to remain the most cost-effective drug in this category, Parikh recommended issuing preferred status to compounded bevacizumab over other anti-VEGF agents while continuing to monitor the ASP and utilization of biosimilars and their reference branded products.

At present, there are 9 ophthalmology biosimilars in the pipeline for macular degeneration and diabetic eye disease: 2 referencing Lucentis and 7, Eylea. All are currently in phase 3 studies, and a decision on MYL-1701P, which references Eylea, is expected sometime this year.

In addition, in the ophthalmology pipeline, there are 3 VEGF inhibitors in development (Eylea HD [aflibercept], Lytenava [bevacizumab-vikg], and KSI-301 [tarcocimab tedromer])—2 gene therapies (RGX-314 and ADVM-022 [ixoberogene soroparvovec]), and a complement inhibitor (Zimura [avacincaptad pegol]).

There are now more treatment options for AMD and DME, and these include biosimilars to Lucentis and a robust drug pipeline, Parikh noted as he concluded his presentation. In addition, it’s necessary for payers to be open to continually evolving their drug management strategies, now that biosimilars are creating market competition and driving down reference product costs, and interchangeability status allows for easier treatment substitution.

“That means plans need to be more watchful for any drops in ASP, changes in utilization and spend, and overall costs of the products,” he said, “to keep spend under control in this category and also lower patient costs.”

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Representatives from Magellan Rx Management provided a detailed overview of current treatment options in ophthalmology and the impact that biosimilars could have during a session at AMCP 2023.

Getting Ophthalmic Biosimilars to Market Continues to Prove Difficult

Since the European League Against Rheumatism’s (EULAR) initial recommendations in 2010 for how to manage rheumatoid arthritis (RA) with disease-modifying antirheumatic drugs (DMARDs), progress in the field necessitated 2 updates in 2013 and 2016. A third update was just released in the 

With clinical remission the main goal of RA treatment, using DMARDs enables symptom relief; improves physical function, quality of life, and social/work capacity; and inhibits structural damage to cartilage and bone.

This most recent update comprises 5 principles and 12 recommendations on the use of DMARDs—conventional synthetic (cs; methotrexate, leflunomide, sulfasalazine), biological (b; tumour necrosis factor [TNF] inhibitors [adalimumab, certolizumab pegol, etanercept, golimumab, infliximab], abatacept, rituximab, tocilizumab, sarilumab), 

, and targeted synthetic (ts; Janus kinase inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib)—and glucocorticoids to treat patients with RA. Included is guidance on mono- and combination therapies, treatment strategies, and tapering treatment. Altogether, this update considers patient benefits, safety, preferences, and costs related to RA treatment.

The 5 principles build on the previous updates, but they are not based on “specific scientific evidence.” Instead, they are overarching and address treating patients with RA:

Treatment should aim to provide the best care that is based on shared decision-making between patient and rheumatologist.

Treatment decisions should be based on disease activity, safety issues, and other patient factors (eg, comorbidities, disease progress, etc).

Rheumatologists should be the primary treating specialist for patients with RA.

Patients’ require and need access to different RA drugs throughout their lives, because the disease is heterogenous and may require a switch to a drug with a different mode of action.

Treating rheumatologists should consider the economic burden patients face when making therapeutic decisions.

The 12 recommendations also incorporate information from the previous updates. However, unlike the principles, they should be followed in this order:

Start DMARD therapy immediately following an RA diagnosis.

Make sustained remission or low disease activity the goal of treatment.

Monitor treatment on a regular basis and adjust as needed.

Incorporate methotrexate in a patient’s initial treatment; it also remains effective in combination with csDMARDs, bDMARDs, and tsDMARDs.

Consider leflunomide or sulfasalazine for initial treatment if methotrexate is contraindicated or a patient exhibits intolerance to it.

Consider short-term glucocorticoids if initiating/changing csDMARDS, but taper as soon as possible.

Switch to another csDMARD if the treatment goal is not reached with the first csDMARD.

Add a bDMARD or tsDMARD to csDMARD therapy if treatment goal is not reached and the patient has a poor prognosis.

Replace csDMARDs with interleukin-6 inhibitors or tsDMARDs when patients cannot use the former.

Incorporate one bDMARD/tsDMARD for another if treatment fails with the initial choice, but for TNF inhibitors that fail, there is a choice to introduce another agent or TNF inhibitor into the treatment regimen.

Scale back on bDMARDs or tsDMARDs in cases of persistent remission, after having already tapered glucocorticoids and when combination treatment includes a csDMARD.

Weight the decision to taper csDMARDs in cases of persistent remission.

These updated guidelines come on the heels of several new drug approvals in Europe after the 2016 update, and several of the principles and recommendations remain unchanged. However, the authors expect them to be revised again, and soon, so that patients can continue to receive optimal treatment from their treating rheumatologists and other stakeholders remain updated on progress in the field.

“We have reached a steady state of the evidence base for patients with established RA, although still some needs remain unmet, including the need to cure the disease. With the current rate of evidence development, we expect an update of the recommendations to be necessary in about 3-4 years,” they concluded.

Smolen JS, Landewé, RB, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update [published online January 22, 2020]. 

Updated guidelines from the European League Against Rheumatism (EULAR), based on new evidence and a review of the literature from 2016 to 2018, address recommendations on the use of disease-modifying antirheumatic drugs and glucocorticoids to treat patients with rheumatoid arthritis (RA). Included is guidance on mono- and combination therapies, treatment strategies, and tapering treatment.
 

Updated EULAR RA Treatment Recommendations Address Patient Concerns, Recent Developments

Seventy-one percent. That is how much the value of the global 

 (MS) drug market is expected to expand between 2016 and 2025: from $16.3 billion to $27.8 billion (USD). Costs per patient per year (PPPY) have risen, too, almost 7X over the past 20 years. Between 1993 and 2014, PPPY costs rose from $9000 to $60,000 (USD). Biosimilars, less expensive but having equivalent efficacy to their innovator biologics, can alleviate some of this spend. However, is the pharmaceutical industry putting patient safety at risk by rushing MS biosimilars to market?

That is the issue at heart in a recent commentary in the journal, 

, distinguished emeritus professor and founder and inaugural director, 

Maxine Mesinger MS Comprehensive Care Center

, Baylor College of Medicine. Rivera, now retired from active direction of the center, focuses much of his time on MS education.

 and how biosimilars are approved, in his opinion, without hard (ie, trial results) proof they actually are similar to their innovator biologic medicines, or are even cost-effective. In Iran, for example, where 101.19 persons per 100,000 have MS, 

 produced biosimilar interferon 1-a and 1-b were approved by the country’s Food and Drug Organization based on limited study results.

“The main priority should always be the protection and well-being of the patient irrespectively of therapy availability or pharmacoeconomic issues,” Rivera noted. “Theoretically, an ideal licensing acquisition would be that each proposed medication presented by the developer or the manufacturing company to the responsible authorities, should provide significant efficacy and safety results based on evidence, obtained through appropriate basic studies and well-designed clinical controlled trials.”

However, he sees the pharmaceutical industry motivated by money above all else, due to “loose national and international legislative control” that has raised the eyebrows of the MS field.

an especially concerning issue in Latin America

. At present, 9 follow-on β-interferons are vying for a share of the market against 3 interferon innovator products, Rivera notes. And their approvals have gone largely unchallenged by any regional licensing agencies. Just Brazil, Chile, Colombia, Panama, and Venezuela have legislation regarding biosimilars. In contrast, no MS biosimilars have been approved by the FDA, European Medicines Agency, the Japans Pharmaceuticals and Medical Devices Agency, or the UK Medicines and Healthcare Products Regulatory Agency.

The best possible solution right now, Rivera concludes, encompasses the following areas:

National and international studies that prove biosimilar similarity to innovator drugs

Providing education on biosimilars to anyone responsible for licensing them

“The patient’s well-being and safety remain as the fundamental principles in treating MS,” he emphasizes.

have suggested that some studies generally undertaken to facilitate biosimilar approval are unnecessary or even unethical in nature.

Rivera VM. Biosimilar drugs for multiple sclerosis: an unmet international need or a regulatory risk? 

2019;8(2):177-184. doi: 10.1007/s40120-019-0145-0.

A recently published commentary examines the global multiple sclerosis (MS) drug market from the perspective of patients and physicians, noting that different regulatory bodies have different standards in place for approvals, and questions if safety concerns are being addressed.

Commentary Questions Differing Global Standards for MS Biosimilar Approvals

, Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer Center in Louisiana, decried the refusal of many insurance payers to add oncology biosimilars to their drug formularies. The cost is steep, she claimed: Patient health is at stake.

The costs of cancer care today have far-reaching implications, with the effects of the high prices of biologic medications inserting themselves in all facets of patient life. 

 often do not fill critically needed prescriptions, bypass important diagnostic tests altogether, or fail to even make appointments to see their healthcare providers, Oubre pointed out. But there are solutions that enable easier access to care.

. These lower-cost alternatives are interchangeable to reference biologics because they “can be expected to produce the same clinical result as the reference product in any given patient.” And healthcare providers, and their patients, should have ready access to this more affordable treatment option.

Instead, biologic originator medications continue to be preferentially prescribed, often due to “anticompetitive rebating practices,” Oubre 

. “Where biosimilars, which are certified as clinically equivalent by the FDA, are the correct treatment option, failure to prescribe them is a failure to address financial toxicity.” This toxicity amounted to an almost 75% increase in 2018 net spending on biologics.

These “fail-first” policies amount to insurers effectively eliminating the lower-cost biosimilars as a treatment option for patients to choose over their more expensive originator biologics. And manufacturers are using questionable rebating practices to force this choice. Last summer, the Federal Trade Commission 

 an investigation into the contracting practices of Johnson & Johnson’s for infliximab originator, and auto-immune drug, Remicade.

Despite claims that rebates benefit their insured populations as a whole, insurers avoiding the competition of biosimilars by not even providing them as an option does nothing to stem long-term price growth. And with more and more oncology biosimilars entering the market, healthcare providers should be able to help their patients reduce their out-of-pockets costs while providing the highest-quality care available, which will lead to savings over time. It’s simply a matter of being able to provide the choice, she wrote.

With the FDA’s updated guidance allowing pharmacists to substitute biosimilars for originator biologics, as they can for small-molecule generics and their brand name counterparts, progress is being made. In October, UnitedHealthcare even 

 biosimilar bevacizumab (Mvasi) and biosimilar trastuzumab (Kanjinti) to its lists of preferred products for commercial and community plans. But much remains to be done.

“The oncology provider community should demand better, making clear that antibiosimilar formulary policies infringe on providers’ ability to offer care in a manner that promotes the best outcomes for our patients,” Oubre emphasized. “Biosimilars may hold the key to savings for patients struggling with financial toxicity.”

In May 2019, the FDA released its final guidance on biosimilars. With more and more oncology biosimilars entering the market, healthcare providers should be able to help their patients reduce their out-of-pockets costs while providing the highest-quality care available, which will lead to savings over time, according to a recent column in Evidence-Based Oncology™, a sister publication to The American Journal of Managed Care®.
 

The Biosimilar Solution to Expensive Cancer Care

Indian private equity firm True North could soon hold a 2.44% minority stake in Biocon Biologics, after its planned merger with Biocon Research, parent company Biocon Ltd 

 in a statement. This is thanks to a $100-million investment approved by the Biocon Biologics Ltd board, which values Biocon Biologics at close to $3 billion. The investment is pending regulatory approval.

“This investment is an endorsement of the value that Biocon Biologics has demonstrated as a global biosimilars player, having commercialized three of its molecules in developed markets like EU, U.S., Japan and Australia,” 

 Kiran Mazumdar-Shaw, MD, chairperson and managing director, Biocon.

True North has invested in Biocon twice before. In 2014, when it was known as India Value Fund Advisors, the fund acquired an almost 10% stake in Syngene, Biocon’s contract research arm, and in 2003, it invested in Biocon in a pre-IPO round (the company went public in 2004).

“Biosimilars is a fast growing industry that addresses a fundamental need of bringing affordability to specialized effective biologic products. Biocon Biologics has been one of the global leaders with their early success in developing and commercializing multiple products across geographies,” added Satish Chander, partner, True North.

 in a new round of fundraising in 2020 that could bring in $200 million to $300 million for Biocon Biologics. Other potential investors include 

, a Singapore government-owned investment firm, and 

, the UK government’s investment arm. The Biologics arm of Biocon has seen enormous growth since it was formed in 2017, and it is on target to hit $1 billion in revenue in fiscal year 2022.

Thanks to its partnership with Mylan, Biocon received its first FDA approval in 2017 for the biosimilar trastuzumab, Ogivri, which recently became 

 in the United States. The biosimilar pegfilgrastim, Fulphila—the first biosimilar to pegfilgrastim available in the United States&mdash;was approved in 2018, and Biocon’s manufacturing facility for it this past November. Altogether, Mylan and Biocon Biologics have produced 11 molecules.

Indian private equity firm True North could soon hold a 2.44% minority stake in Biocon Biologics India Ltd, a subsidiary of Biocon Ltd, thanks to a $100-million investment. The influx of cash values Biocon Biologics at close to $3 billion. The investment is pending regulatory approval.