FDA Approves First Biosimilar Drug; Still No Guidance on Names

The Food and Drug Administration has approved the first biosimilar therapy in the U.S.:electronic-medical-record

Many newer biotech drugs cost more than $100,000 per year, and together they account for nearly 30 percent of all U.S. drug spending. Five of the top 10 U.S. drugs by revenue are biotech medicines, according to IMS Health. Since their introduction in the 1980s, biotech drugs haven’t faced generic competition because the FDA did not have a system to approve copies.

In 2012, the FDA laid out a regulatory pathway to approve so-called “biosimilars.” That’s the industry term for generic biotech drugs, indicating they’re not exact copies. For years the biotech industry staved off competition by arguing their drugs were too complex to be reproduced by competitors. (Matthew Perrone and Linda A. Johnson, Associated Press via Denver Post)

There is a rough – but very imperfect – parallel between biosimilars and generic drugs, which now make up the vast majority of prescriptions filled in the U.S. The innovative biotech industry long argued that it was harder to make a generic biologic therapy than a generic drug, because the former is made from living sources, not just molecules.

The biosimilar in question is Zarzio®, a biosimilar of Neupogen®, used to help cancer patients recover from chemotherapy. The article quotes Express Scripts, a leading pharmacy-benefits manager (PBM), which estimates that the biosimilar will reduce costs by $5.7 billion over the next decade.

Approval of biosimilars opens up a host of patient safety and intellectual property questions. High on this list is what to name them. The FDA has not yet issued guidance. Like Amgen’s Neupogen®, sources refer to Zarzio® by the trademark which Novartis has registered for the product. Its generic, nonproprietary name is filgrastim.

This is a very important issue for patients, doctors, and public policy. For other drugs, once the patents expire and generic competitors launch copycats, the trademarked brand name becomes less important. State laws generally cause pharmacists to dispense generic versions of off-patent medicines, unless a doctor explicitly writes “Do Not Substitute” on a prescription. So, generic drug-makers do not usually worry about the proprietary name for their medicines.

Novartis’ giving its version of filgrastim such a unique trademarked name shows that it intends to differentiate its product from the original, not just market it like it would a traditional generic. This emerging business model ensures that the regulation of biosimilars will be debated hotly for the foreseeable future.


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