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Today, lots of regulatory content! We talk about march-in rights and chastening TikTok influencers for their prescription drug #sponcon.
The need-to-know this morning
- Coherus Biosciences sold Cimerli, a biosimilar version of the eye drug Lucentis, to Sandoz for $170 million. With the transaction, Coherus said it was exiting the eye disease business to focus on cancer.
- Sagimet Biosciences announced results from a mid-stage study of an experimental treatment for MASH, a progressive liver disease.
- The Genentech unit of Roche returned rights to two experimental drugs for Alzheimer’s disease to AC Immune, following the termination of a development partnership.
- Ionis Pharmaceuticals said its injectable treatment called donidalorsen reduced the frequency of severe tissue swelling “attacks” compared to a placebo in patients with hereditary angioedema. The results achieved the goals of a Phase 3 study, and Ionis plans to submit the drug for regulatory approval.
- Autolus Therapeutics said the FDA accepted its marketing application for obe-cel, a personalized CAR-T therapy to treat adult patients with B-cell acute lymphoblastic leukemia. The FDA will render an approval decision on or before Nov. 16.
The pros and cons of march-in rights
March-in rights are controversial: While some say they can be used to help lower drug prices, others say they are a threat to intellectual property. As STAT’s Ed Silverman explains, the use of march-in rights would essentially mean that if the government has helped fund research used by a drugmaker, it can require that company to license its patent to someone else — increasing competition. But the biopharma industry says the exercise of these rights would infringe on profits and, ultimately, intellectual property rights.
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