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Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.
The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.
India’s national list of essential medicines 2022 features 34 additions, including insulin glargine, teneligliptin, lenalidomide, bedaquiline and montelukast, with price control expected to follow on these drugs.
Stakeholders in Europe have been hesitant to allow interchangeable substitution of biological products, prompting the European Medicines Agency to clarify its stance on the issue.
The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.
Following a review of an earlier decision, the European Medicines Agency has confirmed its recommendation to suspend marketing authorizations for dozens of medicines with bioequivalence studies conducted by Synchron Research Services. However, eight products have been spared after alternative supporting data was identified.
With the launch of rivals to Humira looming in 2023, removing barriers to free pricing and reforming formularies will be essential to promote biosimilar competition in the US, according to Wayne Winegarden of the Pacific Research Institute.
European Medicines Agency insisted on a stricter statistical analysis than the US FDA for demonstrating equivalence on the primary endpoint for both Coherus/BioEq’s Cimerli and Samsung Bioepis’ Byooviz; there also were differences in the regulators' preferred primary analysis population and primary endpoint interval.
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