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

Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?

Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?

Biosimilars FDA

Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

Generic Drugs Clinical Trials

Medicines For Europe Highlights Industry Agenda

Ahead of its annual meeting in Malta in mid-June, European off-patent industry association Medicines for Europe has set out the hot topics for generics and biosimilars stakeholders that delegates will be looking to discuss.

Europe Legislation
See All

Pricing Strategies; Reimbursement Explore this Topic

Set Alert for Pricing Strategies and Reimbursement

US Supreme Court Reignites Claims Government Overcharged Millions For Generics

In a case that could have significant ramifications for the scope of the US False Claims Act, the US Supreme Court has agreed to remand for further proceedings allegations that supermarket and pharmacy chains defrauded the government via low-cost drug programs.

Legal Issues Reimbursement

Coherus Plots ‘Lowest Price Adalimumab’ With Huge Discount, Ties Up With Mark Cuban

Coherus BioSciences had teased a “compelling value proposition” for its Yusimry (adalimumab-aqvh) biosimilar to AbbVie’s Humira blockbuster and it has delivered, with a pair of pricing strategies include one though an alliance with self-labelled “disruptor” Mark Cuban.

Biosimilars Pricing Strategies

Ivabradine Prices Rise High Among Recent UK Launches In April

Ivabradine stood out among recently-launched UK generics with an average price rise of more than a third in April, according to the latest figures from market researcher WaveData.

Market Intelligence Pricing Strategies
See All

Intellectual Property Explore this Topic

Set Alert for Intellectual Property

Samsung Bioepis Quiet On Launch Date After EU Soliris Biosimilar Approval

Samsung Bioepis responded to Generics Bulletin enquiries following its EU-wide approval for a biosimilar to AstraZeneca’s Soliris.

Biosimilars Approvals

Medicines For Europe Highlights Industry Agenda

Ahead of its annual meeting in Malta in mid-June, European off-patent industry association Medicines for Europe has set out the hot topics for generics and biosimilars stakeholders that delegates will be looking to discuss.

Europe Legislation

Stelara Settlement Gives Amgen US Ustekinumab Entry Date

A settlement reached in US patent litigation over Janssen’s Stelara will allow Amgen to launch its ABP 654 ustekinumab biosimilar no later than 1 January 2025. It remains to be seen whether other ustekinumab developers will follow suit.

Biosimilars Deals
See All

Market Intelligence Explore this Topic

Set Alert for Market Intelligence

Ivabradine Prices Rise High Among Recent UK Launches In April

Ivabradine stood out among recently-launched UK generics with an average price rise of more than a third in April, according to the latest figures from market researcher WaveData.

Market Intelligence Pricing Strategies

Samsung Bioepis Biosimilars Report Sees Lower Price Boosting Uptake

Samsung Bioepis has published the first in a planned series of reports on the US biosimilars market, including insights into pricing, uptake and market share for various biosimilars.

Biosimilars Market Intelligence

Perindopril And Pramipexole Prices Peak In March

Two products featured highly among the fastest-rising UK generics prices in March, but for different reasons.

Market Intelligence Generic Drugs
See All
UsernamePublicRestriction

Register