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Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

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

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

Remodulin And Revlimid Rivals Join France’s Répertoire

Almost 20 new generic groups – including rivals to Flecaine, Inegy, Remodulin and Revlimid – have been added to France’s répertoire of generic equivalents following the latest update by local medicines agency ANSM.

France Generic Drugs
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Pricing Strategies; Reimbursement 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

Aurobindo Acquires Seven Oncology Injectables From Spectrum

In line with its strategy to establish its presence in the US branded market, Aurobindo has through its subsidiary Acrotech Biopharma acquired seven marketed oncology injectables from Spectrum Pharmaceuticals in a deal worth up to US$300 million.

United States M & A
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Intellectual Property 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

Aurobindo Acquires Seven Oncology Injectables From Spectrum

In line with its strategy to establish its presence in the US branded market, Aurobindo has through its subsidiary Acrotech Biopharma acquired seven marketed oncology injectables from Spectrum Pharmaceuticals in a deal worth up to US$300 million.

United States M & A
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Market Intelligence Explore this Topic

Set Alert for Market Intelligence

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

Aurobindo Acquires Seven Oncology Injectables From Spectrum

In line with its strategy to establish its presence in the US branded market, Aurobindo has through its subsidiary Acrotech Biopharma acquired seven marketed oncology injectables from Spectrum Pharmaceuticals in a deal worth up to US$300 million.

United States M & A
See All
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