Episode 3. The Build Back Better Act and Biosimilars

For a legal perspective on the past year in biosimilars and a look ahead at 2022, Tony Hagen, senior editor for The Center for Biosimilars®, spoke recently with Chad Landmon, chair of the Intellectual Property and Food and Drug Administration Practice Groups at Axinn, a New York–based antitrust, intellectual property, and litigation law firm.

President Joe Biden’s landmark Build Back Better Act (BBBA) legislation would close holes in the public safety net and provide financial stimulus for action on climate change. While the bill would cut carbon pollution and create jobs for a country getting back on its feet after being ravaged by the pandemic, it would also impose a controversial set of pricing controls on drug manufacturers, including price negotiation and, penalties on manufacturers who raise their prices faster than inflation. How biosimilars and generics would be affected by these provisions has been in flux. In this part of the interview, Landmon discusses the changing character of the bill.

He also comments on the spate of earth-shaking moves by companies in the biosimilar space to consolidate or raise capital for expansion. In recent days, Alvotech of Reykjavik, Iceland, said it would merge with a special acquisition company to absorb $450 million in new capital from investors, after which Alvotech intends to launch an initial public offering. Also, Novartis announced that it was conducting a strategic review of its Sandoz operation, which encompasses its biosimilars line of products, for a possible spinoff in the next few years. And, although not officially confirmed, Moneycontrol reported recently that Mylan and Biocon, both biosimilars companies, are in talks for a potential $10 billion merger of their businesses. Citing sources close to the deal, Moneycontrol said Biocon seeks to retain a controlling majority share in the new corporate entity. Both companies are well-established partners on biosimilar and insulin products.

These actions, large on the seismic scale for the biosimilars industry, suggest that the corporate sector.