We're here with our weekly round-up of the top stories in healthcare! This week, we delve into the FDA finalizing the intended use rule, the FTC pulling the pay-to-delay case, the FDA approval of the first insulin biosimilar, and Sanofi's deal with Translate Bio.
After almost a year of delays and anticipation, the US Food and Drug Administration (FDA) has finalized a rule solidifying its position on an intended use rule. The final rule is largely unchanged from the initially proposed rule, apart from some key changes to more explicitly express the new intended use regulations, including the types of evidence it will consider when determining a medical product's intended use. The delays were caused by concerns raised by pharmaceutical and biotech groups who moved to petition the FDA to revert the rule to its original proposal and delete two infrequently enforced clauses, found in 21 CFR 201.128 and 801.4, both of which allow the FDA to regulate products based on their actual uses and whether a manufacturer knows, or has knowledge of information that would indicate that a drug or device will be utilized for reasons outside the product’s intended use. In the Federal Register notice announcing the final rule, the FDA stated: “the fact that intended use can be established through promotional claims does not preclude the possibility that other evidence may be relevant as well.” In the final rule, the FDA declined to meet the insistence that the new rule narrow its interpretation of evidence of intended use to a firm’s promotional claims.
The final rule is set to take effect on 1 September 2021.
The Federal Trade Commission (FTC) has withdrawn a claim in a lawsuit over a “pay-to-delay” deal after the U.S. Supreme Court ruled that the agency does not hold the authority to force companies to relinquish “ill-gotten” profits. This ruling is likely to set forth a precedent making it harder for the FTC to successfully bring antitrust cases against drug makers. This development follows the Supreme Court’s refusal to review an appeals court ruling in response to a lawsuit the FTC had brought against AbbVie, who allegedly conspired with another company to impede availability of lower-cost generics of their AndroGel testosterone treatment. This is at the center of a “pay-to-delay'' deal, an arrangement in which brand-name drug makers settle with a generic rival by bartering in exchange for ending patent litigation and releasing a similar medicine in the future.
The FTC claimed that AbbVie and Besins Healthcare illegally impeded access to lower-cost alternatives to AndroGel and in 2018, a U.S. district court ruled in favor of the FTC forcing AbbVie and Besins to disgorge $448 million in “ill-gotten” profits. However, a U.S. appeals court overturned the lower-court’s ruling because the FTC lacks the federal authority to force disgorgement.
The FDA approved the United States’ first interchangeable biosimilar, insulin glargine. The product, also known as Semglee, can now be automatically interchanged for the reference product, Lantus. This approval gives Semglee 12 months of product exclusivity before another interchangeable biosimilar can be approved. This designation means that pharmacists can now switch patients to the lower-cost version of insulin without clinician approval. Lantus was Sanofi's second best-selling pharmaceutical product in 2020 accumulating $2.7 billion worldwide. Semglee injector pens cost around $150 to $190 monthly without insurance compared to $340 to $520 for the same supply of Lantus.
Sanofi has acquired U.S. biotech company Translate Bio in a $3.2 billion deal, buying all outstanding shares of Translate Bio for $38.00 per share, representing a total value of around $3.2 billion. The deal has been approved by the boards of both companies as well as the Chief Executive of Translate Bio. Sanofi is hoping to expand their mRNA technology platform, furthering research exploring the possibilities of future vaccines and therapies following the success of Pfizer and Moderna’s use of mRNA technology in formulating a COVID-19 vaccine. Sanofi and Translate Bio have collaborated in the past, coming together in 2020 to develop an mRNA-based COVID-19 vaccine, as well as exploring mRNA vaccines for infectious diseases and a possible mRNA-based vaccine against seasonal flu.
Sanofi expects to complete the acquisition in the third quarter of 2021.