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Obama wants to introduce US biosimilars pathway Posted 31/08/2009

US President Barack Obama plans to fund part of his healthcare reform plans by backing an approval pathway for generic biologicals. As reported by Christopher Spillane in Scrip News, Mr Obama lobbied the American Medical Association to support proposals to overhaul US healthcare in a far-reaching address.

Speaking recently in Chicago, USA, the President outlined the economic rationale for his radical overhaul, as US Congress continues to tussle with the concept of extending healthcare coverage to the estimated 46 million uninsured US citizens. President Obama pitched a sum of US$1 trillion (Euros 715.88 billion) over 10 years today against a future loss of several trillion dollars in fiscal growth.

Detailing his wide-ranging reforms, he implored the influential group of doctors to support his plans, including a pathway for the approval of biosimilars. “We need to introduce generic biologic drugs into the marketplace ... But right now, there is no pathway at the FDA for approving generic versions of these drugs,” he said.

He argued that building such a pathway would save the US billions of dollars. The plans first emerged as a part of the US$ 634 billion (Euros 453.5 billion) Health Reserve Fund, announced during his 2010 fiscal budget proposal, which envisioned savings of US$ 9.24 billion (Euros 6.61 billion) over 10 years from the creation of a biosimilars approval pathway.

Although a data exclusivity period has yet to be determined for originator biologicals, executives from the biotechnology industry have suggested protection from generics for up to 14 years.

At the recent Biotechnology Industry Organization (BIO) meeting, Dr Sean Harper, Amgen's Chief Medical Officer, told Scrip that there should be a biosimilars pathway, but it should be focused on patient safety, be science-based and rewards innovation. “We feel what Europe did was very sensible with respect to these parameters. A fair data exclusivity period would be in the 12–14 year range.”

At the same meeting, BIO President and CEO Mr Jim Greenwood said, “I think that if we don't get something around 14 years of data exclusivity and those generic companies can jump in after three to five years then that would pretty much be the death-knell of investments in biologics. You can't recover your investment in that period of time.”

There were concerns at the annual BIO meeting regarding the level of government involvement in the public-plan the Obama administration was proposing. The President moved to quell these fears by noting “when you hear the naysayers claim that I'm trying to bring about government-run healthcare, know this – they are not telling the truth.”

The topic is likely to be contested throughout the summer. Many in government and the industry expect a bill to be passed next year.

Source: Scrip

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