First Biosimilar Insulin Approved By FDA, Can Swap-In For Brand Names

Stat: FDA Approves The First Interchangeable Biosimilar Insulin 
In a long-awaited move, the Food and Drug Administration has approved the first so-called interchangeable biosimilar version of insulin, which the agency suggested may reduce the price of a life-saving treatment that has been a poster child for the high cost of medicines. The agency endorsed Semglee, a copy of long-acting Lantus (insulin glargine), that it first approved last year. Now, though, the copycat version has also been designated as interchangeable, a regulatory term that means Semglee can be substituted at the pharmacy for Lantus in the same way that generic drugs are substituted for equivalent brand-name medicines. (Silverman, 7/28)

AP: FDA Allows Automatic 'Generic' Swap For Brand-Name Insulin
U.S. regulators took action Wednesday that will make it easier to get a cheaper, near-copy of a brand-name insulin at the drugstore. Doctors now have to specifically prescribe what’s called a biosimilar or OK substituting it for a more expensive brand-name insulin. Wednesday’s move by the Food and Drug Administration will allow pharmacists to automatically substitute the cheaper version, just as they do with generic pills for other kinds of drugs. (Johnson, 7/28)

In other pharmaceutical industry news —

Bloomberg: Doctors Blast Biogen Alzheimer Approval As ‘Regulatory Failure’
Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.” The New England Journal of Medicine opinion piece, signed by seven members of an advisory panel that opposed clearing Biogen’s Aduhelm, is another sign of persistent furor over the agency’s decision. Two committees of the House of Representatives investigating the approval have asked the Cambridge, Massachusetts-based biotech to turn over documents about the drug’s development and approval. (Langreth, 7/28)

Stat: Why Aduhelm's Approval Can't Guarantee A Golden Age Of Alzheimer's R&D
Since the controversial approval of the Alzheimer’s drug Aduhelm, both the Food and Drug Administration and the drug’s maker, Biogen, have made an interesting argument: that approving the medicine will speed the development of other Alzheimer’s treatments, whatever one thinks of this medicine’s efficacy. “If we look at the past experience, progress has to be made with the first step, and we can look at HIV, oncology, or [multiple sclerosis],” Biogen’s CEO, Michel Vounatsos, said on the company’s earnings call last week. His remarks echoed those of Patrizia Cavazzoni, who heads the FDA center that regulates new medicines. (Herper, 7/29)

Boston Globe: Deep Genomics Raises $180 Million To Automate Drug Discovery
Brendan Frey, the founder and chief executive of Deep Genomics, thinks the wrong people are developing new drugs to treat genetic diseases. In fact, he doesn’t think humans should be doing most of the work. It’s Frey’s view that the next wave of medicines will be discovered using artificial intelligence, and he has support from big investors to create a company that could do that: Deep Genomics on Wednesday announced a $180 million funding round led by Softbank Vision Fund 2, with participation from Fidelity Management & Research Company and others, bringing its total venture haul to $240 million. (Gardizy, 7/28)

CIDRAP: Oxford Launches Early Clinical Trial Of Plague Vaccine
Oxford University this week announced the phase 1 trial launch of a vaccine against plague, based on the same adenovirus platform that researchers used to develop the AstraZeneca-Oxford COVID-19 vaccine. The trial will take place in 40 healthy adults ages 18 to 55 and will assess safety and how well the vaccine triggers protective antibody and T-cell responses, Oxford said in a press release. Volunteers will be followed for 12 months. (7/28)