Biosimilar Bytes

The biosimilar news streaming over the past couple of weeks has been interesting, with an important update of a crucial story to the biosimilar field. We commented on some of the more noteworthy items below.

Date Set for Supreme Court Arguments in ACA

November 10 is the date now set by the US Supreme Court to hear oral arguments over the constitutionality of the Affordable Care Act (ACA). This date will be a week after the presidential election. The Supreme Court will have to determine whether the individual mandate to have health insurance, which was removed three years ago, renders the entire ACA unconstitutional. In doing so, it could invalidate the Biologics Price Competition and Innovation Act (BPCIA), which authorizes the pathway for biosimilar approval by the Food and Drug Administration. As covered earlier in BR&R, the courts have not been in agreement as to whether the ACA can be severed from the individual mandate, and also whether the BPCIA (among other sections of the ACA) can be severed from the parent legislation. The November court date may translate to a Supreme Court decision in June 2021.

Creative Scoring System on Biosimilar Use in Europe

Industry consultant IQVIA has introduced a simple scorecard for understanding the differences among European countries regarding their approach and experience with biosimilars. Rated by level of competition, how prices have been affected, and biosimilar uptake, the scorecards have a look that is reminiscent of NCCN’s Evidence Blocks. IQVIA’s scoring system also address the sustainability of biosimilars in each country, through a number of measures. These include the type of tenders and contract length (and whether these contracts are exclusive), physician switching policies, the existence of patient incentives to use biosimilars, the inclusion of biosimilars in clinical guidelines, among others.

Celltrion Seeking Oral Infliximab Next

Last November, Celltrion received EMA approval to license its subcutaneous form of infliximab in Europe. The South Korea–based biosimilar maker isn’t stopping there. It recently announced that it is in the early phases of developing an oral form of infliximab, as well. An oral form could well have a dramatic effect on the market for this drug (along with some gastrointestinal side effects that often accompany the transition to this route of administration).

Although Celltrion has not mentioned any intention of bringing this oral product to the US market, it does intend to submit a 351(a) application for FDA approval of the subcutaneous form. That approval could upend the biosimilar market for infliximab (depending on pricing), because of its implications on site of care as well as pharmacy versus medical benefit management.  

In other Celltrion news, it is starting phase 1 clinical trials of CT-P41, a biosimilar version of denosumab for the treatment of osteoporosis. This biosimilar is not expected to complete clinical trials until 2025, with a marketing application submitted in 2026.

Johnson & Johnson Purchases Momenta

Johnson & Johnson announced on August 24 that it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc, formerly a player in the biosimilar market for $6.5 billion. Momenta still has one biosimilar under development, M710, which is a biosimilar version of aflibercept (Eylea®) to treat wet age-related and diabetic macular degeneration. This agreement places J&J in bed with Mylan, which was contracted to develop M710 on Momenta’s behalf. Mylan confirmed in late February that it is still moving forward with development of the agent, also known as MYL-1701P. A phase 3 trial in the treatment of diabetic macular degeneration is scheduled to be completed in December 2020 (primary completion was in February), and Mylan says it expects a 351(k) submission by early 2021.

AAM Names New Executive Director

On August 25th, the Association for Accessible Medicines (AAM) announced that its new President and Chief Executive Officer will be Dan Leonard, former President and CEO of the National Pharmaceutical Council (NPC). Mr. Leonard takes over for Chip Davis, whose tenure with AAM ended in February.

Carol Lynch, President, Sandoz US and Head, Sandoz North America, and Vice Chair of the AAM Board of Directors, said in a press release, “We are confident that Dan will lead the association’s talented team to support our work with the Administration and Congress to further secure the pharmaceutical supply chain and create market conditions that will ensure the long-term viability of the generic and biosimilars industry.”

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