Democrats determined to see 'biogeneric' bill through

By Susan Gotensparre

- Last updated on GMT

US Democrats spearheaded by Henry Waxman intend to re-table a
stalled piece of legislation that would allow US Food and Drug
Administration (FDA) approval of generic biodrugs, which they claim
would result in cost savings for patients and healthcare payers.

A senior member of the House Energy and Commerce Committee, Waxman drafted the bill - the access to life-saving medicine act - supported by senators Hillary Rodham Clinton and Charles Schumer, that was introduced in Congress (H.R. 6257/S. 4016) last year.

Biotechnology products are now part of mainstream medicines, although many have now lost patent protection. The FDA, unlike its European counterpart the European Medicines Agency, has been unable to come up with a regulatory framework to bring generic versions to market, so far.

Biotechnology companies claim the complex nature of biologics means it is hard to show that a 'biogeneric' behaves in the same way as its branded equivalent and are asking for safety and effectiveness testing to be included in the bill. If the bill is successful, generic biodrugs or 'follow-on-biologics' will have a significant impact on competition and pricing of protein-based therapeutics.

With a total value of $20.2bn in global sales, insulin, human growth factor, epoetin, colony stimulating factors, interferon alpha and interferon beta are all now susceptible to competition from biogenerics. Overall biologic drug product sales jumped 17.2 per cent in 2005 to $32.8bn (€25.4bn), according to IMS Health

"There is currently no generic competition for biotech drugs, which are one of the fastest growing and most expensive category of drugs on the market today,"​ Henry Waxman, United States House of Representatives, told

"So this month, I intend to re-introduce my legislation from last Congress to authorize FDA to approve generic versions of biotech drugs. This legislation leaves it to FDA to decide, on a product-by-product basis, when the science is there to show that a generic version of a biologic is safe and effective. Seeing this legislation enacted will be one of my highest priorities in this Congress."

The PCMA (Pharmaceutical Care Management Association) are confident in the FDA's authority to review and evaluate the science supporting an application process, due to its twenty years experience in reviewing biotechnology products, in terms of manufacturing and purification principles.

PCMA also states that successful reproduction of life-saving 'follow-on biologics' will lower a patient's yearly costs by tens or even hundreds of thousands of dollars and welcomes a competitive production market.

The Biotechnology Industry Organisation (BIO) argues that manufacturing cost cuttings are overstated but are unified in wanting a competitive market and for people to get access to drugs.

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