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Coherus Claims Pegfilgrastim Payer Parity, But Parries Sales Queries

Coherus BioSciences is hailing US payers’ responses to its January launch of its Udenyca pegfilgrastim biosimilar; but the US-based developer sidestepped investors’ questions around sales figures.
Biosimilars Pricing Strategies Reimbursement

UK’s CMA Will Not Take Action Over Remicade Discount Scheme

The UK’s competition regulator will not take action against MSD over a suspected anti-competitive discount scheme for Remicade (infliximab), despite an earlier provisional finding that MSD had a dominant market position and the scheme was in breach of competition law.

Legal Issues Biosimilars United Kingdom

Canadian Body Welcomes Pharmacare Report

An interim report on implementing national pharmacare in Canada that highlights the importance of cost savings and access to medicines has been welcomed by local off-patent industry body the CGPA.

Market Intelligence Canada Generic Drugs
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Commercial Explore this Topic

Eastern European Results Roundup: Grindeks, Alkaloid, Olainfarm, Podravka, Sopharma

Several Eastern European generics companies achieved sales growth in 2018. Looking ahead, Grindeks plans to strengthen its presence in Russia and other CIS countries, Alkaloid is set to continue investing in production facilities and technologies, while Olainfarm looks to upgrade its product dossiers.

Europe Companies

Sandoz Head Francis To Leave Amid Move Towards Autonomy

Sandoz’ drive to greater efficiency and stronger profit margins through a group-wide transformation process has prompted the division’s global head, Richard Francis, to step down.
Leadership Appointments

Accord Agrees Leuprolide Deal as Part of Differentiation Strategy

Accord is furthering its push into added-value medicines by entering into a licensing agreement for Foresee’s injectable suspension leuprolide injectable.
Value-Added Medicines Deals

Zentiva Set To Acquire Romania's Solacium

Zentiva has signed its first acquisition after it was carved out from Sanofi last year to become an independent company, entering into a shared purchase agreement with Siyiara to acquire Romania-based food supplement and OTC medicines producer Solacium.

Romania M & A

FDA Approves Pfizer's Trastuzumab Biosimilar

Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.

Biosimilars Regulation

Amneal Targets Up to 50 Launches, But Fears Diminishing Returns

Amneal has a solid roster of generics lined up for introduction in the US this year; but challenging market dynamics are forcing the company to reassess the commercial potential of these launches.
Launches Strategy
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Policy & Regulation Explore this Topic

Industry Alliance Supports Commission On Environment

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Regulation Europe

Novitium’s Pyridostigmine Shows Six Appeal Of CGT Pathway

In granting its sixth approval for an ANDA with a Competitive Generic Therapy (CGT) designation, the FDA insists it is fostering competition in the US off-patent market.
Approvals Generic Drugs

CREATES Act Will Not Lead To Frivolous Lawsuits, Says AAM's Davis

Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.

Pricing Debate Generic Drugs

FDA Approves Pfizer's Trastuzumab Biosimilar

Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.

Biosimilars Regulation

Venipharm Gets European Enoxaparin Nod

Venipharm has received approval for its enoxaparin through the European decentralized procedure. The product was developed in collaboration with China’s Nanjing King-Friend Biochemical Pharmaceutical.

Europe Regulation

FDA Sticks To Its Guns On Biosimilar Naming

In the face of calls from the biosimilars industry to rethink its position on biological naming conventions as being out of step with other major territories, the FDA has issued fresh guidance that reinforces its commitment to using four-letter suffixes for both biosimilars and new brand biologics, as well as confirming that the names of any biosimilars designated as ‘interchangeable’ will bear a suffix. At the same time, the agency has rowed back on previous proposals to retroactively add a suffix to already-licensed biologics.

Regulation Biosimilars
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Latest From Generic Drugs

Alvogen Fails In Revlimid IPR Attempt

Alvogen’s inter partes review petition challenging a Revlimid patent in the US has been denied by the PTAB, following similar denials of petitions by Dr Reddy’s over three other Revlimid patents.

Intellectual Property United States

Saphris Asenapine Ruling Is Bounced Back By US Appeals Court

District court errors on failing to address potential motivation to develop sublingual formulations, as well as on claim construction for label carve-outs, have led the US Court of Appeals to vacate and remand a patent validity and infringement ruling on Allergan’s Saphris asenapine antipsychotic.
United States Intellectual Property

Industry Alliance Supports Commission On Environment

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Regulation Europe
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Latest From Biosimilars

Alvotech Starts European Trial For High-Concentration Adalimumab

Icelandic developer Alvotech is looking to set itself apart from the pack offering biosimilar rivals to Humira by conducting a Phase III clinical trial for an alternative to AbbVie’s high-concentration 100mg/ml version of adalimumab, the world’s best-selling drug.
Biosimilars Immune Disorders

Industry Alliance Supports Commission On Environment

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Regulation Europe

Sandoz Head Francis To Leave Amid Move Towards Autonomy

Sandoz’ drive to greater efficiency and stronger profit margins through a group-wide transformation process has prompted the division’s global head, Richard Francis, to step down.
Leadership Appointments
See All

Latest From Value-Added Medicines

Accord Agrees Leuprolide Deal as Part of Differentiation Strategy

Accord is furthering its push into added-value medicines by entering into a licensing agreement for Foresee’s injectable suspension leuprolide injectable.
Value-Added Medicines Deals

Celltrion’s Subcutaneous Infliximab Shows Promise

Data revealed by Korea’s Celltrion demonstrates that the firm’s subcutaneous infliximab is comparable to the intravenous formulation, with a study showing that auto-injection is a viable administrative method.

Biosimilars Strategy

TLC Seeks A Second Opinion On Doxolipad

After the CHMP last month refused to recommend granting approval for TLC’s doxorubicin hybrid, the firm has asked the committee within the EMA to revisit its opinion.

Europe Regulation
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