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Biosimilars

Set Alert for Biosimilars

German Medicines Safety Law Will ‘Do Nothing Against Shortages’

A provision in new German legislation that requires insurance funds to consider a variety of suppliers will do nothing to address drug shortages because it is not obligatory, local industry association Pro Generika believes.

Germany Legislation

Lupin Q1 Profit Up 50% But Regulatory Overhang, Slow Product Scale-Up Sparks Concern

Lupin’s first-quarter net profit soared nearly 50%, but the strong performance was overshadowed by concerns about regulatory overhang and slower-than-expected scale-up of new products that could jeopardize future revenue growth momentum.

Manufacturing Business Strategies

US Appeals Court Denies Genentech Injunction Over Amgen's 'At Risk' Trastuzumab Launch

Genentech has been denied its request for a US injunction against Amgen over its at-risk launch of a trastuzumab biosimilar rival to Herceptin.

Biosimilars Intellectual Property

Two Weeks Remain To Enter Industry Awards

Firms now have until 23 August to enter the Global Generics & Biosimilars Awards 2019.

Generic Drugs Biosimilars

Sandoz Will Appeal Against US Enbrel Patent Setback

Sandoz expects to bring an expedited appeal against a US district court’s finding that two patents protecting Amgen’s Enbrel etanercept brand until 2028 and 2029 are valid. 

Biosimilars Intellectual Property

IGBA Urges Balance In EU-Australia Trade Deal

International off-patent industry body the IGBA has urged Australia’s government to “hold firm” against intellectual-property proposals made by the European Commission as part of negotiations over an Australia-EU trade deal. The organization believes the EU proposals would negatively impact access to generics and biosimilars in Australia.

Intellectual Property Trade
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