Battle ahead for US industry over biologics patents
pharmafile | June 12, 2009 | News story | Research and Development, Sales and Marketing |Â Â PhRMA, US, generics, industry, reformÂ
Moves to make it easier for biosimilars to be approved in the US are gaining momentum.
The pharma industry has conceded that the reforms will come – but wants to guarantee longer patent protection on biologicals in return.
The more complex manufacturing process needed to produce biologicals and a lack of legal clarity about patents have been obstacles for generics companies looking to market biosimilars.
Congressman Hank Waxman is one of Washington’s campaigners for health reform, and is pushing for new biosimilars legislation to be included in a package of changes to the US healthcare system.
The Obama administration has made reform of the country’s health system one of its top priorities, and drug prices are now under scrutiny. President Barack Obama has set a target of cutting $2 trillion from US healthcare spending over the next decade.
This is equivalent to cutting the growth rate of national healthcare spending by 1.5% points annually, which if successful, would end years of above inflation growth in healthcare spending.
Waxman is demanding President Obama includes measures in forthcoming legislation to remove the obstacles which currently make launching biosimilars in the US very difficult.
Pharmaceutical industry lobby group PhRMA is one of many interest groups to have put forward its own solutions to the US healthcare funding crisis. and has even proposed a biosimilars approval pathway.
This approach represents a change of tack for the industry, which hopes that by offering its own solutions it can influence the final legislation. In exchange for concessions towards easier biosimilar approvals, PhRMA wants to see patent protection of at least 14 years on biologicals.
The arguments are now shifting to how long patents on biologicals should be, with the industry pushing for 14 years protection. But a new report by the Federal Trade Commission has rejected claims that a 12-14 year period is justified.
The FTC report concludes that this period is unnecessarily long, and adds that original biological products are likely to retain substantial market share after biosimilars are launched, unlike traditional small molecule drugs where generics quickly swamp the market.
Hank Waxman has welcomed the report, saying it “completely disposes of the drug industry’s argument” that 12-14 years of marketing exclusivity is needed.
“The FTC has provided an unbiased, expert analysis of all the arguments and has definitively concluded that patents and market-based pricing provide more than enough incentive to invest in important new medicines,” Waxman said. “This is good news for consumers, who will have early access to affordable versions of life-saving drugs without compromising future breakthroughs.”
PhRMA point out that growth in prescription drug costs has already started to level off. Analysts IMS Health project that the US market will remain essentially flat until at least 2014.
But the cost of healthcare is crippling for the many US citizens who still have to pay for a large proportion of their prescription drug costs. This means other measures, such as allowing parallel imports of cheaper medicines from abroad are being proposed again.
This plan is unlikely to be made law, but PhRMA will have a major battle on its hands to maximise the market exclusivity on biologicals.
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