FDA Withdraws Guidance On Biosimilars, Conceding A Different Approach Is Needed To Get Them To Market
“Biosimilars foster competition and can lower the cost of biologic treatments for patients,” said FDA Commissioner Scott Gottlieb. “Yet the market for these products is not advancing as quickly as I hoped.”
Stat:
Frustrated At The Pace Of Biosimilar Development, FDA Yanks A Draft Guidance
In an unusual step, the Food and Drug Administration withdrew a draft guidance that was issued last fall to help companies develop biosimilar medicines that resemble brand-name biologics. By doing so, the agency acquiesced to concerns expressed in recent months by companies over some of the recommendations that were made for concocting a biosimilar, which is a nearly identical variant of a biologic medicine and is expected to provide the same result in patients. (Silverman, 6/21)
In other pharmaceutical news —
The Hill:
Skyrocketing Insulin Prices Provoke New Outrage
Rising insulin costs are drawing outrage from diabetes advocates, leading to calls for greater transparency and federal oversight of the market for a drug that helps more than 7 million Americans. Insulin was first discovered nearly 100 years ago, and as newer forms of the drug have been introduced, the price has climbed. (Weixel, 6/21)
California Healthline:
California Poised To Expand Access To Hepatitis C Drugs
Patrick Garcia wasn’t completely surprised when he learned recently he had hepatitis C. Until a few years ago, he had experimented with numerous drugs, injecting heroin, methamphetamine, cocaine — you name it. “I haven’t lived exactly a perfect life,” said Garcia, 43, whose mouth, hand and back were injured in a motorcycle wreck last year.Medi-Cal, California’s public health program for the poor, paid for his post-accident care and the bloodwork that led to his hepatitis C diagnosis. But it wouldn’t pay for the pricey new medications that cure the disease. (Bartolone, 6/21)
