Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Regulation

Set Alert for Regulation

Sandoz: Big Cap Biosimilar Rivals Lack Clarity On Commitment

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Biosimilars Strategy

GDUFA Research Impacting Generic Development, ANDA Approvals

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

Generic Drugs Research & Development

FDA Seeks New Generics Chief As Choe Moves On

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.

Leadership Executive Changes

Pharma Readies For Price Caps On Glargine, Teneligliptin, Lenalidomide In India

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.

Policy India

EMA And HMA Speak Out In Favor Of Biosimilar Interchangeability

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.

Biosimilars Europe

EU Gears Up For Compulsory Licensing Reform

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.

Intellectual Property Europe

EMA Confirms Recommendation Of Synchron Suspensions

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.

Regulation Europe

‘Significant Discounts’ For Biosimilars Could Disrupt US Market

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.

Biosimilars Pricing Strategies

Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements

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.

Biosimilars Drug Review
See All
UsernamePublicRestriction

Register