Policy and Regulation
Regulation Explore this Topic
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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?
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New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific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.
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.
Pricing Strategies; Reimbursement Explore this Topic
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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.
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.
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.
Intellectual Property Explore this Topic
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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.
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.
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.
Market Intelligence Explore this Topic
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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.
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.
Perindopril And Pramipexole Prices Peak In March
Two products featured highly among the fastest-rising UK generics prices in March, but for different reasons.
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