Biologics Price Competition and Innovation Act: Striking a Delicate Balance Between Innovation and Accessibility

The Biologics Price Competition and Innovation Act: Potential Problems in the Biologic-Drug Regulatory Scheme

The approval process for biosimilar erythropoiesis-stimulating agents.

A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage ...

The constitutional protection of trade secrets and patents under the Biologics Price Competition and Innovation Act of 2009.

The Biologics Price Competition and Innovation Act of 2009 ("Biosimilars Act") is for the field of pharmaceutical products the single most important legislative development since passage of the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"), on which portions of the Biosimilars Act are clearly patterned. Congress revised section 351 of the Public Health Serv...

The market for follow-on biologics: how will it evolve?

With spending on biologics rising and patent expiry approaching for several blockbuster biologics, Congress and the Food and Drug Administration are considering creating a clear pathway for so-called follow-on biologics. Differences between drugs and biologics will affect market outcomes in various ways. Conservative budget impacts are appropriate in the short run because fewer competitors will...

نقش حقوق رقابت در بهبود سلامت عمومی

Competition as an important incentive for innovation leads to freedom of choice and price reduction and contributes to more rapid provision of new and effective therapeutic technologies. On the other hand, anti-competitive practices adopted by economic undertakings in the health sector may disrupt competition including limited access to medicines and medical services or increase in their price....