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Regulation

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Teva And Hikma Plan Long-Term Environmental Commitments

Teva has disclosed plans to focus on climate action and resilience, responsible use of natural resources and emissions, effluents and waste, as part of a long-term environmental sustainability commitment. Meanwhile, Hikma has at the same time committed “to further reducing our climate impact and improving the resilience of our business in the face of future climate change.”

Generic Drugs Policy

New UK Biosimilars Pathway Suffers Setback

The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.

Biosimilars Regulation

Interchangeability, Meetings And Access Among BsUFA III Priorities

Industry stakeholders have offered their views on key priorities for the BsUFA biosimilars user-fee program ahead of its reauthorization.

Biosimilars FDA

UK-EU Deal Allows For ‘Significant Divergence’ In Data Protection & SPCs

The agreement on trade and cooperation between the UK and the EU requires both sides to offer regulatory data exclusivity and supplementary protection certificates, but it does not specify any minimum periods of protection.

Intellectual Property Regulation

US FDA Recalibrates Office Of Generic Drugs

As part of a wider overhaul of the FDA’s Center for Drug Evaluation and Research, the agency is reorganizing its Office of Generic Drugs, including adding a new Office of Safety and Clinical Evaluation within the OGD.

Regulation FDA

Viatris And Biocon’s US Bevacizumab Hit By Indefinite Delay

Viatris and partner Biocon have seen FDA action on their application for a bevacizumab biosimilar rival to Avastin delayed by the need for a facility inspection, the timing of which is uncertain due to coronavirus-related restrictions.

Biosimilars Regulation
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