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Sandoz Says All Options Still Open After Spinoff Rumors

Sandoz has responded to recent rumors that parent company Novartis is favoring a spinoff of the generics and biosimilars business over a sale or retention, insisting that “all options remain open” as a strategic review of the unit continues.

Strategy M & A

Interviews

Interviews

Competition Intensifies As Access Increases For US Biosimilars

At an eventful time for US biosimilars, a fresh wave of players entering the market is expected to both increase competition and broaden access, AmerisourceBergen’s senior vice president for global emerging therapies and channel strategy Beth McMahon tells Generics Bulletin.

Biosimilars United States

GGB Awards Return To Frankfurt In November

The Global Generics & Biosimilars Awards returns to Frankfurt this November, celebrating the greatest achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars Value-Added Medicines
 

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Sandoz Says All Options Still Open After Spinoff Rumors

Sandoz has responded to recent rumors that parent company Novartis is favoring a spinoff of the generics and biosimilars business over a sale or retention, insisting that “all options remain open” as a strategic review of the unit continues.

Strategy M & A

Citeline And Norstella Merge To Provide End-To-End Solutions For Pharma

Publisher’s Spotlight: Citeline, the publisher of Generics Bulletin, is to merge with fellow pharmaceutical solutions provider Norstella.

Companies Commercial

Grindeks Sets Out Plans For International Expansion

Latvia’s Grindeks has set out plans to expand internationally, including by opening new subsidiaries in the US, Switzerland and EU, following a year of growth for the company.

Strategy Sales & Earnings

Henlius Denosumab Biosimilar Trial Enters Phase III

Henlius has administered the first dose in its international Phase III trial into its denosumab biosimilar candidate, HLX14. The firm has also revealed that its new Songjiang plant has been granted GMP equivalence with EU practices.

Clinical Trials Biosimilars

Glenmark Bolsters US OTC Portfolio With Wockhardt Products

Glenmark has moved to bolster its over-the-counter business in the US by acquiring a portfolio of approved generic OTC products from Wockhardt.

Deals Generic Drugs

Aurobindo Reprimanded By SEBI Over US FDA Warning Disclosure

The Securities and Exchange Board of India has warned Aurobindo that it did not disclose sufficient information about a US FDA warning letter that it received in connection with its Unit 1 API facility in Hyderabad early this year.

Compliance Manufacturing
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Policy & Regulation Explore this Topic

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GDUFA Collections Fell Short In FY 2021

The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.

User Fees Generic Drugs

What’s Next? Five Things To Look Out For In July

This month, long-awaited new pricing measures in Canada will come into force, while several trials will either kick off or end, including a liability opioids case involving Teva in San Francisco and Hatch-Waxman litigation over Otsuka/Lundbeck’s Rexulti.

Generic Drugs Biosimilars

Amgen Sees Acceleration In US Biosimilars Market

The US marketplace for biosimilars is accelerating faster than the EU at a similar point in its existence, based on approval rates, Amgen has observed in a preview of its 2022 trends in biosimilars report that also offers new data on pricing and uptake.

Market Intelligence Biosimilars

Biosimilars Forum Welcomes PBM Transparency Act

Senators Maria Cantwell and Chuck Grassley have introduced a bill which would limit pharmacy benefit managers’ ability to engage in “unfair and deceptive” business practices, a move which has been welcomed by the Biosimilars Forum.

Legislation Regulation

Aurobindo Reprimanded By SEBI Over US FDA Warning Disclosure

The Securities and Exchange Board of India has warned Aurobindo that it did not disclose sufficient information about a US FDA warning letter that it received in connection with its Unit 1 API facility in Hyderabad early this year.

Compliance Manufacturing

EMA Re-Examines Decisions On Prestige’s Trastuzumab And Synchron Studies

Following decisions by the EMA’s CHMP to deny Prestige Biopharma a marketing authorization for its trastuzumab biosimilar and to suspend the marketing authorizations of dozens of generics due to concerns over bioequivalence tests, the European regulator has confirmed it will review the opinions.

Biosimilars Generic Drugs
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Generic Drugs Explore this Topic

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GDUFA Collections Fell Short In FY 2021

The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.

User Fees Generic Drugs

UK’s NHS Cites Significant Savings From Generics And Biosimilars

Savings made through the use of generics and biosimilars have been highlighted by the UK’s NHS, with the organization pointing to savings of £1.2bn over three years, a third of which came from Humira biosimilars alone.

Generic Drugs Biosimilars

What’s Next? Five Things To Look Out For In July

This month, long-awaited new pricing measures in Canada will come into force, while several trials will either kick off or end, including a liability opioids case involving Teva in San Francisco and Hatch-Waxman litigation over Otsuka/Lundbeck’s Rexulti.

Generic Drugs Biosimilars
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Biosimilars Explore this Topic

Set Alert for Biosimilars

GDUFA Collections Fell Short In FY 2021

The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.

User Fees Generic Drugs

UK’s NHS Cites Significant Savings From Generics And Biosimilars

Savings made through the use of generics and biosimilars have been highlighted by the UK’s NHS, with the organization pointing to savings of £1.2bn over three years, a third of which came from Humira biosimilars alone.

Generic Drugs Biosimilars

What’s Next? Five Things To Look Out For In July

This month, long-awaited new pricing measures in Canada will come into force, while several trials will either kick off or end, including a liability opioids case involving Teva in San Francisco and Hatch-Waxman litigation over Otsuka/Lundbeck’s Rexulti.

Generic Drugs Biosimilars
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Value-Added Medicines Explore this Topic

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180 Life Sciences Adalimumab Study Publishes Positive IIb Dupuytren’s Disease Data

Adalimumab could find itself with a tenth official indication, after 180 Life Sciences found that it was able to effectively treat nodule hardness and size in Dupuytren’s disease during a phase IIb study.

Biosimilars Value-Added Medicines

What’s Next? Five Things To Look Out For In June

In June, Medicines for Europe will host its annual and legal affairs conferences in Barcelona, while on the commercial side Hikma’s CEO Siggi Olafsson is to resign from the London-listed company.

Biosimilars Generic Drugs

Stada And Calliditas Celebrate European Nod For Budesonide Hybrid

The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.

Europe Regulation
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