Experts expect to see “second wave” of biosimilars approvals

Regulatory NewsRegulatory News | 02 June 2021 |  By 

Craig Burton, John Brooks, Sean McGowan, Nick Adolph

Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges hobble uptake, according to presenters discussing the current landscape and future projections for the biosimilars market at the annual meeting of the Association for Accessible Medicines (AAM) on 27 May.
“We have come a long way in the last two years,” said Craig Burton, vice-president of policy for AAM. Where you used to see one or two biosimilar products reference innovators in a single category, now we have multiple categories that have two or more biosimilar products, indicating to me that the market is healthy and there are opportunities for manufacturers to launch in the US.”
Janet Woodcock, acting commissioner of the US Food and Drug Administration, made the same observation at the meeting, noting a “significant increase” in biosimilars approvals as the pharmaceutical industry has shown renewed interest in developing these drugs. (RELATED: Woodcock cites vigorous interest in biosimilar development, Regulatory Focus 28 May 2021)
Second wave coming
Sean McGowan, the senior director of biosimilars at AmerisourceBergen, predicted that a “second wave” of biosimilar approvals will soon be occurring as the FDA approves more products in an expanded list of categories.
Currently, there have been approvals in three categories: supportive care, oncology and tumor necrosis factor (TNF) blockers.  However, the biosimilar pipeline is filled with investigational biosimilars in ophthalmology, immunosuppressants and bone health, said McGowan. Also in the pipeline are biosimilar versions of infertility drugs, insulin and human growth hormone.
McGowan added that the second wave of approvals will come from generic manufacturers such as Anneal, Accord, Lupin and Dr. Reddy. The entry of these firms into the biosimilar business is a development that will “raise the level of competition” for these products.
Reimbursement challenges
While the pipeline is growing, the one dark cloud is that the Medicare Part D program discourages further development of biosimilar drugs.
Under the existing Part D program, sponsors are given more incentives to place patients in higher cost brand biologics than biosimilars.  Because the discounts provided by brand biologics are included in the calculation of the patient’s true out-of-pocket cost, plans are incentivized to place patients on a higher-priced brand biologic that will move patients through the coverage gap and into catastrophic coverage faster and with lower out-of-pocket costs compared to a lower-cost biosimilar, according to an AAM fact sheet.
John Brooks, a partner in South Capital Consultants, said, "We will have to see how the Biden administration views biosimilar policies." He added that “There is a bipartisan consensus that Medicare Part D needs to be reformed….There is an agreement that payers should take on additional catastrophic benefits.”


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Tags: Biosimilars

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