Five things for pharma marketers to know: Thursday, August 27
The FDA on Wednesday released new draft guidance for the naming of biosimilars, proposing an approach that would add a suffix to biologic names and their interchangeable biosimilars. The FDA-designated suffix would be unique for each product and would be given to both the biosimilar and its reference product, according to a blogpost on the FDA's website. An example of a nonproprietary name for a reference product would be replicamab-cznm and its biosimilar would be replicamab-hixf.
An article published in Diabetes Care said a new class of recently approved cancer treatments known as anti-PD1 antibodies, such as Merck's Keytruda and Bristol-Myers Squibb's Opdivo, may be tied to a rare form of diabetes. The authors said a Caucasian woman with no history of diabetes was eventually diagnosed with a rare type of diabetes common in East Asian populations—an exceptional case of fulminant type-1 diabetes. She had received her second injection of Keytruda as a melanoma treatment two weeks prior to her visit to the ED. Researchers said there had been five other instances of insulin-dependant diabetes developing in patients being treated with anti-PD1 antibodies.
Amgen's PCSK9 inhibitor, Repatha, is expected to receive its approval decision from the FDA on Thursday, one month after Sanofi's and Regeneron's PCSK9-inhibitor Praluent scored its approval from the agency. An FDA advisory panel recommended Repatha for approval in an 11-4 vote in June.
The Financial Times reported that Abbott was about to propose a $25 billion bid to acquire St. Jude Medical, a move that would create the third-largest medtech company in the world. An Abbott spokesperson denied the report's validity soon after, telling Reuters it was not pursuing the company.
Novo Nordisk acquired two private drugmakers, Calibrium and MB2, both of which specialize in treatments for metabolic diseases like diabetes and obesity, according to Genetic Engineering and Biotechnology News. Novo Nordisk also announced Wednesday that it would invest $2 billion in new production facilities in Clayton, NC, and Måløv, Denmark.