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29-01-2013 | Article

The battle over biologics goes state-level


New York Times


medwireNews: Amgen and Genentech are proposing bills to various states that would limit pharmacists' capacity to provide generic versions of brand name biologic drugs.

If passed, the bill would prevent physicians from prescribing generic biologics of top-selling cancer (bevacizumab, trastuzumab) and rheumatoid arthritis treatments (adalimumab). Not taking advantage of generic options, which the Affordable Care Act (ACA) envisions and is pushing for, would preclude a competitive market and the lowering of drug prices.

A minimum of eight states have introduced the industry-backed bill so far with the Virginia House of Delegates already passing one last week with a vote of 91-to-6.

The issue that is of concern to both manufacturers and regulators pivots around the potential difficulty in producing exact substitutes for biologics when the intricacies of the biotechnology and manufacturing process can lead to slight variances that ultimately result in dissimilar final products.

In a 2012 white paper published in Bloomberg Law, Stanton Lovenworth of O'Melveny's & Myers LLP and member of Health Care and Life Sciences Practice explained that "even minor differences in a protein can significantly impact its function, potentially causing dangerous side effects."

Marketing opportunities for products that are similar to - and at times interchangeable with - biologic products, or "biosimilars," have only recently developed thanks to the Food and Drug Administration (FDA) granting approval to follow-on biologics in the 2010 Biologics Act, which requires demonstrated safety, purity, and potency.

Because biologics are more sensitive than small-molecule drugs that are chemically manufactured, the innovator brand-name drug industry and other proponents are urging a more considered, selective approval process to avoid the risk for possible adverse events due to inconsistent manufacturing, storage, and handling.

Industry is also using the risk for biosimilar drug irregularities as an argument for biosimilars to have unique names - rather than share the brand name - to better keep track of safety monitoring of medicinal products.

But generic manufacturing companies argue that their track records in the biosimilars market warrants their use of the reference product's name, which they claim is also for the sake of safety as well as cost.

Approximately one-quarter of the $320 billion in total spending on medicines in the USA stems from therapeutic proteins and other biologically made drug products that are not chemically manufactured, according to healthcare information and service company IMS Health.

"Although biologics and pharmaceutical innovators alike face the specter of competition brought on by the expiration of their patents, until recently the generics industry has focused only on pharmaceutical substitutes, which have enjoyed the simplified path to approval created by the Hatch-Waxman Act in 1984," Lovenworth wrote.

By Peter Sergo, medwireNews Reporter