Fulfilling the promise of biosimilars has proven more elusive than initially expected. Learn how healthcare stakeholders are evaluating a biosimilars market.
Earlier this week, the Food & Drug Administration (FDA) released a Part 15 public hearing announcement and request for comment on how the FDA can facilitate greater availability while balancing competition and innovation for all biologics.
Most people are familiar with generic drugs as less costly alternatives to drugs whose patents have expired.
In the US, an interchangeability designation by the Food & Drug Administration (FDA) is perceived as the holy grail in biosimilars development by some and yet regarded as irrelevant by others.
New research from Avalere finds that most health plans are covering at least one of the two biosimilar products currently on the market.
Biosimilars have the opportunity to foster competition, but policy and market barriers limit the growth of a functioning market.
With the recent announcement of the U.S. Food and Drug Administration's (FDA) acceptance of a submission for approval of a second biosimilar to Remicade (infliximab), questions remain for biologics manufacturers, payers, prescribers, and others as to how a mature biosimilars pipeline will begin to evolve in the United States and whether a sustainable competitive specialty market will develop.
Two Potential Policy Changes Would Reduce Out-of-Pocket Costs for Consumers
In Biosimilars, Avalere's Gillian Woollett shares commentary on future considerations for the role of clinical trials in the development of biosimilars.
On Aug. 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).
Avalere impressions on the first FDA biosimilar filing.
On May 13, FDA released a draft guidance describing the clinical pharmacology data needed to support a demonstration of biosimilarity to a reference product.