Editor’s Note:  This brief news update follows yesterday’s reprint of Dr. Anthony Sabatelli’s and Dr. Cambria Alpha-Cobb’s article in Pharmaceutical Patent Analyst entitled “Will Purple Become the New Orange? The New FDA Purple Book for Biologics: What Does the Future Hold?

The FDA just approved the first biosimilar drug, breaking the way for a new industry of drugs that could change the forecast of drug spending in the USA. In the simplest definitions, a biosimilar is comparable to the generic form or a copy of a biological drug. They differ from the reference drug in that they could contain differences in materials or methods of manufacture. They are meant to replicate or copy the reference biologic but because they tend to be much larger and highly complicated, than common small molecule drugs, these differences only make them highly similar, not identical, hence “bio-similar”.

The approval of these complicated “copy” medications paves the way for a new market with expanded treatment options and competition that may lead to reduced treatment costs. However, there are a few hurtles that the FDA still needs to address before this market expands too far. For one, the FDA needs to clarify the requirements for classification as an interchangeable drug. This designation would allow the biosimilar to be substituted for the reference drug without the intervention of the health care provider who prescribed the reference product. This would highly increase the likelihood of its use and acceptance into the medical community. The FDA approved Novartis’s Zarxio to treat all five of the indications for which Amgen’s reference drug is approved, yet it was very clearly approved only as a biosimilar, not as an interchangeable (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm). The FDA has not made it clear what further data or evidence would be necessary to obtain this classification.

Additionally the FDA should address a policy for how biological products marketed in the U.S. should be named. This is a complicated issue as future approvals may or may not include all the indications for the reference drug, and confusion between versions could carry serious repercussions for the patient. The FDA, however, has failed to provide any guidance on the process. This first approval has a designated placeholder nonproprietary name for the product “filgrastim-sndz” referencing both the reference drug and the new manufacturer. The agency intends to issue a guidance on the naming policy, but has yet to do so. The longer the issuance of the policy is delayed will only add to the complexity and confusion of the naming scheme as more biosimilars are expected to be approved this year. Until they agree on a formal policy the FDA should recommend a scheme of maximum clarity to eliminate confusion.

Confusion could further delay the inclusion of biosimilars into our health care systems and keep these more cost-friendly alternatives from the people who need them.


 –   Anthony D. Sabatelli, PhD, JD and Cambria J. Alpha-Cobb, PhD


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