The industry has been wrestling for years now over naming the first wave of biosimilars building on the coast of the American drug industry. A lot of companies that develop biosimilars, and that group includes some major corporations, wanted to use the same generic--or nonproprietary--names as the branded drugs, looking to make it easier to carve their way into some blockbuster drug franchises. And a lot of those major brand name franchisors wanted something completely different, forcing the biosimilar crowd to market these drugs like a new arrival--a costly and time consuming affair that would help limit any discounting that may have to come after biosimilar competition hits.
The FDA's suggested solution: Take the generic name and add four random letters to make it a unique identifier. That way you can track any adverse events associated with the knockoff--helping satisfy companies like Amgen ($AMGN), which say this debate is all about drug safety--while making it relatively simple to steer patients to the less expensive alternative. Not coincidentally, this approach would make it easier for practitioners to see all the relevant drugs bunched together in their electronic databases.
Under this rule, Sandoz's version of Amgen's Neupogen (filgrastim, which Novartis will sell as Zarxio) becomes filgrastim-bflm, and the rest of the rivals crowding in would all get their own unique four-letter code. The proposed rule comes closer to the international groups like the WHO which are eager to see some more price competition in the industry. And while BIO and PhRMA haven't come up with their own responses, you can expect that there will be a continuing debate over the name game.
Noted Gal Ronny at Bernstein: "We'll be shocked if the innovative industry, notably those with products at near-term biosimilar risk (like Amgen and AbbVie), do not fight this. Their argument would be that the FDA is not going far enough in requiring different suffixes, and should require different generic names to protect the public."
Biosimilars like Zarxio have already been marketed in Europe for years, but have been effectively barred in the U.S. as the FDA slowly hammered out the rules for development and marketing. Now that Neupogen is the first up to face a whole new generation of rival therapies, the last of the barriers are coming down, as competition in the biosimilars market starts to heat up considerably.
- here are the suggested rules