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Generics Explore this Topic

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First Sabril Rival Sees FDA Deliver On Prioritizing Competition

Prioritizing the approval of generics of medicines with little or no competition has been a key part of the FDA’s efforts to support access and reduce costs to patients; the agency has just granted Teva approval for the first generic version of Lundbeck’s Sabril (vigabatrin) 500mg tablets.

Generic Drugs Approvals

European Council Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing

Wockhardt Wins Review Of Ban On Indian Combination

Evidence put forward by manufacturers to support fixed-dose combinations must be considered by an advisory committee to India’s government, the Delhi High Court has ordered in a verdict favouring Wockhardt.
India Regulation
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Biosimilars Explore this Topic

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Korean Court Upholds Rituximab Ruling, Affirming Victory For Celltrion’s Truxima Biosimilar

An obstacle in Celltrion’s path to sell its rituximab biosimilar in Korea has been removed, with a court’s affirmation that a patent covering Genentech/Biogen’s Rituxan original for the use of chronic lymphocytic leukemia is invalid.

Biosimilars Intellectual Property

Samsung Bioepis’ Trastuzumab Biosimilar Is Third Cleared By FDA – But The Market Hasn’t Formed Yet

Sued by Herceptin sponsor Genentech for patent infringement, Samsung Bioepis has legal hurdles to navigate before it can roll out its trastuzumab biosimilar in the US, which has just become the third biosimilar of the cancer treatment greenlit by the FDA.

Biosimilars Approvals

Belgium Unveils Incentives For Biosimilar Adalimumab And Etanercept

Belgium has introduced financial incentives to encourage doctors to prescribe anti-TNF biosimilars adalimumab and etanercept outside of hospitals.

Belgium Biosimilars
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Value-Added Medicines Explore this Topic

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Sandoz Phases US Epinephrine Entry

Sandoz will first focus on the US institutional channel on which it is increasingly concentrating its attention as it rolls out its alternative to Mylan’s EpiPen epinephrine auto-injector.
Value-Added Medicines Launches

Dr Reddy’s Growth Strategy Sets Sights On Six Spaces

Dr Reddy’s chief operating officer Erez Israeli says six key areas – the US, China, Russia, India, APIs and hospital drugs – underpin the Indian company’s growth ambitions, with small-molecule generics remaining the firm’s “bread and butter”.

United States India

Kashiv Pharma Swallows Up Adello Biologics, Becoming Kashiv BioSciences

New Jersey-based Kashiv adds biosimilar assets to its repertoire by acquiring Adello Biologics, becoming, in its own words, a “fully-integrated biosciences company with an expanded and dynamic platform for growth.” Adello’s CEO, Chintu Patel, will lead the combination.

M & A Biosimilars
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