Earlier this week, we discussed the growth of biosimilars and biobetters. Today, we continue that discussion with FDA guidelines and addressing key concerns.
FDA Guidelines Begin to Address Key Concerns
Naming and labeling clarity are essential for market acceptance of biosimilars.
“Approved biosimilar products have been determined to be highly similar to an FDA-approved reference [originator] product and demonstrated that they have no clinically meaningful differences from the reference product in terms of safety, purity and potency,” says Leah Christl, Ph.D., associate director for therapeutic biologics and lead of the Therapeutic Biologics and Biosimilars staff in the Office of New Drugs at the FDA. “To address biosimilar labeling in particular, we have issued detailed recommendations to industry in the ‘Labeling for Biosimilar Products’ draft guidance.”
The FDA guidelines focus on avoiding any confusion between a biosimilar and the originator drug. They guidelines also recommend that biosimilar product labeling incorporate relevant data and information from the FDA-approved labeling for the reference product, as well as appropriate modifications specific to the biosimilar product.
The FDA is currently reviewing comments it received regarding the draft guidance previously issued on nonproprietary naming of biosimilar products, which also focus on avoiding confusion.
Creating a Value-Added Strategy for the New Biosimilar Market
As is the case with the development and launch of any new drug therapy, success will be measured by whether:
- Pharma can control development costs
- There is a designated chronic or acute market for the drug (i.e., the originator drug has lost exclusivity or there is clear evidence of need for an alternative)
- Providers and patients gain confidence in biosimilars, especially when treatment with an originator drug has been successful
- The price differential warrants switching from the originator drug
- Payers and plans reimburse for biosimilars
Many considerations go into developing a long-term market strategy for a new entry in the drug therapy arena. However, to be successful, a market strategy must:
- Include an optimized, efficiently resourced clinical development program that ensures safety and delivery
- Identify and address potential access, perception and reimbursement hurdles
- Be value-based to attract payers, plans and providers, and to build a comfort level that supports prescribing and reimbursing biosimilars
- Focus on educating stakeholders, including patients, about biosimilars in general and individual biosimilar products specifically
- Include post-approval surveillance to monitor and document the product’s safety profile
“Unlike novels, where the product is the focus of differentiation and you are striving for best-in-class status,” says Darwin Cox, strategy and commercial innovation director for Merck & Co., Inc., “with biosimilars, the product is similar to the originator so the services surrounding that product become a means of differentiation and are the key to becoming the preferred choice against competitors.”
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