With 20 Biosimilars Available, U.S. Market Is Heating Up
In an October 2020 healthcare industry report, the authors projected that biosimilars could hit $80 billion in aggregate sales and provide savings in excess of $100 billion in aggregate over the next five years. Precision’s Dan Danielson joins other industry experts to discuss the impact of biosimilars in 2020 and the forecast for the biosimilars landscape going forward.
With 20 Biosimilars Available, U.S. Market Is Heating Up
As of the beginning of February, the FDA had approved 29 biosimilars. For various reasons, mostly patent litigation by reference drug companies, only 20 of those products actually have launched onto the U.S. market. But as the biosimilars market has yet to demonstrate its full potential, it certainly seems to be picking up steam. In a report released in October, the IQVIA Institute for Human Data Science projected that over the next five years, biosimilars could hit $80 billion in aggregate sales and provide savings in excess of $100 billion in aggregate. AIS Health spoke with a variety of industry experts on what we’ve seen over the past year and what we might expect looking forward.
The available products span seven reference drugs consisting of three supportive care drugs — two biosimilars of Neupogen (filgrastim), one of Epogen/Procrit (epoetin-alfa) and four of Neulasta (pegfilgrastim) — three oncology brands — three biosimilars of Rituxan (rituximab), two of Avastin (bevacizumab) and five of Herceptin (trastuzumab) — and one tumor necrosis factor inhibitor, Remicade (infliximab), which has three biosimilar versions on the market.
Could you please comment on biosimilars’ impact in 2020?
Dan Danielson, R.Ph., senior director of the access experience team at PRECISIONvalue: “We’ve finally seen significant uptake in the…marketed biosimilars, despite the fact that none of them are approved as interchangeable with the originator. Additionally, the majority of biosimilars approved for use in the U.S. are provider-administered. This will impact adoption by providers relying on buy and bill. Providers will need to analyze the financial impact of adoption for each product to maximize their margins.
“I expect we will see manufacturers of originator products work diligently to stave off marketing of biosimilars via patent litigation and strive to maintain their market share once a competing biosimilar is launched. This should not be surprising, as manufacturers have a fiduciary responsibility to their shareholders to maximize returns.
David Lassen, Pharm.D., chief clinical officer at Prime Therapeutics LLC: “The first biosimilars for Herceptin, Avastin and Rituxan all launched in 2019. In 2020, three additional Herceptin biosimilars, one additional Avastin biosimilar and one additional Rituxan biosimilar launched. Through August 2020, Prime’s commercial book of business reflected the following biosimilar market share for those products:
- Avastin biosimilar market share: 46%.
- Herceptin biosimilar market share: 42%.
- Rituxan biosimilar market share: 20%.
“Biosimilar market shares are growing, even with the coverage of the originator product. This has created a lot of competition and reduced costs. Overall, it seems that oncologists are comfortable using biosimilar products.”
Mesfin Tegenu, R.Ph., CEO of RxParadigm, Inc.: “The market must adopt biosimilars, and a concerted effort must be done not to discourage use of biosimilars. Already we’re starting to see, over the last few years, that there has been an increase in the uptake of biosimilars, particularly in the oncology space. This in part is due to prescribers gaining familiarity with biosimilars and manufacturers being successful in capturing significant market share by pricing biosimilars competitively. In terms of market share among the oncology biosimilars, bevacizumab biosimilars now have 37% of the market, trastuzumab biosimilars have 35%, rituximab biosimilars have 17% to 20%, and infliximab biosimilars have 15% to 20%. Among the short-acting granulocyte-colony stimulating factor products, filgrastim biosimilars now have 72% of the market, while pegfilgrastim biosimilars now have 42% of the long-acting GCSF market.”
Michael Zeglinski, senior vice president and CEO of specialty and infusion pharmacy at OptumRx: “Biosimilars are a natural fit for oncology since many of the most expensive, brand-name biologics are used in cancer treatment. Biosimilar developers are well aware of that, which is why, of the six new biosimilar launches in 2020, five are for cancer. All told, as of mid-2020, 16 of the FDA-approved biosimilars are indicated for cancer treatment or for supportive care.
“The pipeline looks like more of the same: There has been nearly 70% growth in the number of biosimilars aimed at cancer over the last seven years; today over half of all biosimilars in development are for cancer indications. We also know that launching new drugs is one thing, but giving physicians the knowledge they need to prescribe biosimilars with confidence is another. AmerisourceBergen conducted a physician survey late last year and found 74% of respondents identified physician confidence as one of the biggest barriers to widespread adoption of biosimilars.
“Guidance from professional associations seems to help drive adoption rates. That’s why it was key when earlier this year the National Comprehensive Cancer Network (NCCN) revised its biosimilar guidelines to indicate that they are appropriate substitutes for FDA-approved biologics. Additional best-practice advice for oncologists is to educate themselves about specific biosimilar manufacturers, which includes knowing if a manufacturer has a reputable distribution partner. These partners are playing an increasing role in connecting biosimilar manufacturers with channel management strategies, while providing access to the tools needed to implement patient assistance and drug replacement programs.”
What do you expect we will see within the biosimilars landscape next year?
Lassen: “Prime expects to see additional biosimilars come to market for reference brands that already have marketed biosimilars, which will create additional competition and push brand and biosimilar manufacturers to compete even further on price. Now that biosimilars are gaining more market share in the U.S., national and regional health plans have been picking preferred biosimilars through medical policy/UM [i.e., utilization management]. Prime expects this trend of picking preferred products to continue. There are 12 additional biologics with projected loss of exclusivity through 2025. This pipeline could impact current negotiation for future leverage. New-to-market biosimilars in 2021 may include Lucentis for macular degeneration. This would be the first biosimilar approved for this condition.”
Kedar Karkare, Ph.D., intelligence analyst at CB Insights: “The biosimilars market is projected to grow over 18% annually, and we expect to see the proportion of new drugs that are biosimilars increase. This trend is likely to drive continued biopharmaceutical supply chain innovation because biosimilars are temperature and time sensitive and thus require consistent monitoring throughout the supply chain to ensure integrity.”
Tegenu: “The biosimilar landscape still continues to grow, and it’s expected that over the next year, we will see additional biosimilars for insulin products that should increase competition and decrease costs. There’s also a possibility we may see an interchangeable biosimilar insulin product, which would allow a pharmacist to be able to substitute it for the reference product without the approval of a physician. We expect biosimilar uptake to continue to grow and provide real savings.”
Zeglinski: “While these new launches are welcome, we should expect another pause on account of various patent and legal maneuverings. Over the next five years, patents on several biologics will expire; however, current clinical trials for biosimilars are only focused on a few molecules. An analysis by the OptumRx pipeline monitoring team indicates that the next big wave of new biosimilar launches won’t hit until 2023. The next wave of biosimilars will target autoimmune conditions like rheumatoid arthritis. Pipeline activity continues to primarily focus on four molecules. Patients will be self-injecting these medications. And while many rheumatology formularies today continue to prefer originator brands, the prescriber groups are actively advocating for biosimilar adoption.”
Contact Danielson via Tess Rollano at trollano@coynepr.com, Karkare via Keith Swiader at keith.swiader@cbinsights.com, Lassen via Jenine Anderson at jenine.anderson@primetherapeutics.com, Rubinstein at elan.b.rubinstein@gmail.com and Zeglinski via Jenny Pavlovich at jpavlovich@Diplomat.is.
by Angela Maas
