Posted tagged ‘Generic Biologic Drugs’

The Ongoing Legislative Debate over Generic Biologic Drugs

November 18, 2013

Biologic DrugsDr. Lindsay Rosenwald of Opus Point Partners co-manages one of the premier biotechnology investment funds available today. As an entrepreneur with a background in medicine and nearly three decades of experience in financing and incubating biotechnology firms, Dr. Lindsay Rosenwald has established himself as one of Wall Street’s preeminent biotechnology investors.

During the summer of 2013, various state-level legislative battles took place as pharmaceutical companies encouraged policymakers to enact physician notification requirements regarding generic biologic drugs. These companies, led by Amgen and Genentech, have faced resistance from pharmacists and the Generic Pharmaceutical Association, which represents manufacturers of generic drugs.

Biologic drugs are especially complex molecules which require exacting manufacturing processes to produce. Hence, generic versions tend to be “biosimilar” rather than identical to brand-name drugs: they behave the same medically without necessarily being perfectly chemically identical.

Because biologics currently make up around a quarter of the $320 billion market for medications in the U.S., the ways in which their generic versions are approved, tested, and regulated are worth tens of billions of dollars to the different actors in the pharmaceuticals industry. So far, in all but one of the fourteen states where the measures have come up for debate, the generic manufacturers have prevailed.

In the coming decade, patents on several high-profile biologics will expire and the FDA will be faced with approving generic versions. Legislation like doctor notification rules will impact many aspects of the generic drug industry.