US considering eight years protection for biologicals in China

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US considering eight years protection for biologicals in China

INICIO/Políticas y legislación | Posted 07/06/2019 0 Post your comment

Makers of copy biologicals in China may be set to get a further boost, as the Trump administration is said to be considering conceding to China’s proposal to shorten the period of protection granted to US drugmakers’ biologicals in the country.

China is reportedly offering eight years of data protection for biologicals. This compares to the 10 years of protection under the North American Free Trade Agreement (NAFTA) [1] and the 12 years of protection under American law [2]. However, in the Trans-Pacific Partnership (TPP) agreement, although the US tried to push for inclusion of intellectual property provisions consistent with US biologicals exclusivity standards, i.e. 12 years of data exclusivity. The final agreement included only five years of market exclusivity for biologicals [3].

US Trade Representative (USTR) Robert Lighthizer and his deputy Jeffrey Gerrish have told pharma companies that China is dug in on its offer for eight years and the US pharma industry is being pushed to accept that deal. The USTR has also reportedly threatened to remove the issue from the trade negotiations altogether if the industry pushes back. However, the US pharma industry has been reported as saying that the USTR kept them in the dark throughout the negotiations.

China is the world’s second-largest pharmaceutical market. The country has a huge market for copy biologicals, with 40% of China’s US$1.5 billion recombinant biologicals sales coming from copy biologicals, which have enjoyed compound annual growth rate (CAGR) of approximately 25%–30% over the past decade [4]. If this deal goes ahead, it will allow Chinese makers of copy biologicals to make their own cheaper versions more quickly.

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References
1.Online - Generics and Biosimilars Initiative. Mexico trade deal impacts biologicals exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Policies-Legislation/Mexico-trade-deal-impacts-biologicals-exclusivity
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars and US exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-and-US-exclusivity
3. GaBI Online - Generics and Biosimilars Initiative. Mexico trade deal impacts biologicals exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Policies-Legislation/Mexico-trade-deal-impacts-biologicals-exclusivity
4. Derbyshire M. Regulation of copy biologicals in China. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):75-6. doi:10.5639/gabij.2018.0702.015

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Source: Bloomberg, Swissinfo