Innovators Employ Labyrinthine Defenses To Fend Off Biosimilars
Innovators are using increasingly complicated tactics in the high-stakes game of keeping biosimilars at bay to ensure their brand-name medicines can keep hauling in the cash for as long as possible.
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A three-judge panel from the US Court of Appeals for the Federal Circuit on July 5 ruled that the 180-day notice of commercial marketing applies to all biosimilar applicants, giving a win to Amgen over Apotex. But in its latest interpretation of the US biosimilars law, the court appears to suggest the FDA needs to establish a tentative-style approval approach for those products, similar to what's employed for generic drugs.
Biopharmaceutical industry lobbying efforts are expected to jump into overdrive on Capitol Hill to get Congress to ban the use of the broadest reasonable interpretation by the US Patent & Trademark Office Patent Trial and Appeal Board after the Supreme Court backed the standard for conducting inter partes reviews – trial proceedings created five years ago to be a faster and more affordable alternative to challenging patents in the courts.
The Patent Trial and Appeal Board of the US Patent & Trademark Office has agreed to hold a trial under its inter partes review process to consider the validity of one of AbbVie Inc.'s dosing methods patents. The challenger, Coherus BioSciences Inc., is hoping to eventually market a biosimilar of Humira in the US.