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Biosimilars bill offers 12 years' marketing exclusivity

Published on 19/03/09 at 08:57am

The US moved one step closer to creating a market for biosimilars - substitutable versions of branded biologic drugs - after a bill describing a regulatory route to approval was re-introduced in Congress.

If implemented, the Pathway for Biosimilars Act will make it possible to market 'generic' versions of biologic drugs in the USA for the first time.

Steven Burrill of biotechnology investment firm Burrill & Co told delegates at the Interphex show in New York, just ahead of the bill's introduction, that the new Obama Administration has signalled its determination to bring biosimilars to the US in a bid to reduce healthcare costs.

Europe has had equivalent legislation in place since 2003 and the first handful of biosimilars are already on the market.

But the US has been much more cautious because it is hard to show conclusively that a biosimilar - sometimes referred to as a follow-on biologic - behaves the same way as the originator drug when it comes to safety and efficacy.

Because there is a close relationship between a biologic's manufacturing process and its clinical attributes, conventional notions of bioequivalence - which underpin the small-molecule generic drug market - do not apply. For that reason there is no truncated regulatory path for biosimilars that corresponds to the FDA's Abbreviated New Drug Application (ANDA) process for small-molecule drugs.

The new bill has won widespread support, largely because it lays out a framework for demonstrating the purity, safety and effectiveness of biosimilars based on non-inferiority studies and that should safeguard patient safety but still encourage price competition in the marketplace. Critically, it also provides a minimum of 12 years' market exclusivity for novel biologics before biosimilar rivals can be approved.

"With this legislation, we can create a pathway to lower-cost copies of biotech drugs without sacrificing safety or eliminating incentives to create breakthrough medicines," said Inslee, who serves on the House Energy and Commerce Committee.

The pharma industry is also clearly on board with the proposal. The bill "provides patients with the right balance between innovation and competition," said Jim Greenwood, president of the US Bioindustry Organization (BIO), in a statement.

The BIO took a very different stance earlier this month over a rival biosimilars bill - introduced for the third time by Henry Waxman - that would grant the originator drug just five years' exclusivity. That bill is "full of potholes" according to the industry body, and "jeopardizes the continued development of new breakthrough therapies".

In the past the BIO has called for at least 14 years' exclusivity.

Divakar Ramakrishnan, executive director of manufacturing science and technology at Eli Lilly, told the Interphex meeting that the requirements for biosimilars still require a significant investment of $100 million or more and four to six years to demonstrate non-inferiority.

Furthermore, "a typical large molecule drug only has a benefit in 30% of patients who take it," he added, "so there is still a pressing need for innovation."

That viewpoint was also voiced by Tim Moore, senior vice president, global supply chain, at Genentech. "We welcome the introduction of biosimilars as a necessary development with significant healthcare benefits," he said.

It is fitting that biosimilars, with proven efficacy and safety, should provide price competition for first-generation biologics, he said. Just as in the past, Genentech will stick to its model of investing in innovation to bring forward the "next generation of medically-effective products," Moore concluded.

Related stories:

Are biosimilars delivering the goods in the EU?

Sunday, March 08, 2009

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