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Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

US Generics Approvals Will Decline

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Generic Drugs Regulation

Harmonization Needed For Complex And Value-Added Drugs

Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.

Europe Regulation

Regulatory Measures Could Mitigate EU Coronavirus Risks

As part of its response to the coronavirus outbreak, Medicines for Europe has set out a series of policy recommendations that it says could help to mitigate the risks of COVID-19.

Regulation Europe
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Pricing Strategies; Reimbursement Explore this Topic

Set Alert for Pricing Strategies and Reimbursement

Beximco And Mylan Strike Biosimilars Deal

Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.

Deals Biosimilars

Upsher-Smith Launches Three New Generics

Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.

Launches Generic Drugs

US Generics Approvals Will Decline

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Generic Drugs Regulation
See All

Intellectual Property Explore this Topic

Set Alert for Intellectual Property

Beximco And Mylan Strike Biosimilars Deal

Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.

Deals Biosimilars

Upsher-Smith Launches Three New Generics

Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.

Launches Generic Drugs

US Generics Approvals Will Decline

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Generic Drugs Regulation
See All

Market Intelligence Explore this Topic

Set Alert for Market Intelligence

Beximco And Mylan Strike Biosimilars Deal

Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.

Deals Biosimilars

Upsher-Smith Launches Three New Generics

Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.

Launches Generic Drugs

US Generics Approvals Will Decline

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Generic Drugs Regulation
See All
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