Can Biologics Manufacturers Face Antitrust Risk For Pointing Out That Biosimilars Are Different?

• Published date: 18 August 2021
• Subject Matter: Anti-trust/Competition Law, Food, Drugs, Healthcare, Life Sciences, Antitrust, EU Competition , Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Haug Partners
• Author: Mr David Shotlander

Biologics are revolutionizing the pharmaceutical industry, and in doing so, garnering an increasing share of antitrust attention. In recent years, the FTC, FDA, and antitrust plaintiffs' bar have raised concerns about a perceived lack of biologics competition. In particular, these groups have observed that biosimilars have not taken substantial market share from their corresponding biologics or caused significant price erosion; thus, biosimilars have not replicated the impact of generic competition on small molecule brand drugs. This observation has prompted some to claim that biologics manufacturers are stifling competition by disparaging those biosimilar products, which may raise antitrust concerns.¹

To properly analyze alleged biosimilar disparagement, it is first helpful to understand the statutory framework for biosimilars. Biologics differ from small molecule drugs, which are required to have the same active ingredients as those of their brand competitors. By contrast, biologics are derived from natural biologic sources. Therefore, biosimilar sponsors must perform studies that demonstrate that there are no clinically meaningful differences between the biosimilar and the original or reference biologic product. In addition, the manufacturing processes for biosimilars are costly and require more research and development investments than generic drugs. This poses a substantial barrier to biosimilar manufacturers looking to compete with biologics already on the market. On account of this problem, the statutory framework for FDA approval of biologics differs from small molecule drugs.² Several important definitions from the Biologics Price Competition and Innovation Act³ include:

• A "biologic" refers to "a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment or cure of a disease or condition of human beings."⁴
• A "biosimilar" in reference to a biologic means "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product."⁵

The statute makes a distinction between "biosimilars" and...