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Amneal Makes It Three With Pegfilgrastim Approval

Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.

Biosimilars Approvals

Coronavirus Spotlight

Coronavirus Spotlight

WHO Urges Pfizer To Broaden Generic Paxlovid MPP Deal

As Pfizer’s Paxlovid joins the World Health Organization’s prequalification list, the organization has passed down several recommendations to the US-based Big Pharma, including expanding the scope of countries supplied under an MPP generic licensing agreement.

Coronavirus COVID-19 Generic Drugs

Interviews

Interviews

Samsung Bioepis ‘Setting A High Bar’ For Next Wave Of Biosimilars

In the wake of parent company Samsung Biologics completing its full acquisition of Samsung Bioepis, the Korea-based biosimilars player has told Generics Bulletin that it will be a “more robust company,” as it applies more rigorous standards to replenishing its pipeline of biosimilar candidates.

Biosimilars Companies

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
 

Commercial Explore this Topic

Set Alert for Commercial

Zydus Looks To Revlimid Opportunity, Pivots To Multivariant COVID-19 Vaccine

Zydus is looking to launch a Revlimid generic in the second wave while an opportunity might soon emerge from Takeda’s Pentasa. It is also pivoting to a multivariant version of its plasmid DNA vaccine against COVID-19, ZyCoV-D, after the original didn’t receive an encouraging response.

Strategy Sales & Earnings

Centrient Hails Milestone For Clean Antibiotic Production

Centrient has celebrated passing a “significant milestone in the clean production of antibiotics” after meeting Predicted No Effect Concentration discharge targets set by the AMR Industry Alliance across its entire oral antibiotics product range.

Manufacturing Supply Chain

Amneal Makes It Three With Pegfilgrastim Approval

Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.

Biosimilars Approvals

Teva Inks $100m+ Deal To Settle West Virginia Opioid Claims

Teva has struck a further cash-and-medicines settlement agreement to resolve opioid-related claims in the US. A bench trial had been due to start in West Virginia by the end of this month, where Teva is to pay $75m over 15 years plus generic Narcan.

Legal Issues Deals

Olon Invests In R&D Hub In Italy

Italy’s Olon has announced a €10m investment in a new R&D hub in Rodano, Milan, that the active pharmaceutical ingredient specialist says will help to consolidate its expertise and connect its worldwide network of 11 facilities.

Research & Development Manufacturing

Henlius Brings In Abbott As Another Partner In Brazil

Chinese player Shanghai Henlius Biotech has out licensed semi-exclusive rights to some of its biosimilars in Brazil again, shortly after signing a major deal covering 16 Latin American countries.

Biosimilars Deals
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies

The EMA’s CHMP has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Regulation Europe

AAM Calls For FTC Scrutiny Of Pharmacy Benefit Manager Practices

Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

Generic Drugs Biosimilars

Gemme Welcomes Advent Of French Biosimilar Substitution

French off-patent industry association Gemme has welcomed the entry into force of biosimilar substitution – but has protested against recent and ongoing price cuts for small-molecule generics in the context of unprecedented cost pressures.

Biosimilars France

Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research

ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.

Generic Drugs Combination Products

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

Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

Biosimilars Regulation
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

Momenta Sues Viatris Over Copaxone Generic – Five Years After Launch

One Copaxone (glatiramer acetate) ANDA sponsor is suing another for alleged patent infringement, with Momenta filing a lawsuit against Viatris and its partners in a US district court.

Legal Issues Intellectual Property

EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies

The EMA’s CHMP has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Regulation Europe

AAM Calls For FTC Scrutiny Of Pharmacy Benefit Manager Practices

Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

Generic Drugs Biosimilars
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

Amneal Makes It Three With Pegfilgrastim Approval

Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.

Biosimilars Approvals

AAM Calls For FTC Scrutiny Of Pharmacy Benefit Manager Practices

Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

Generic Drugs Biosimilars

Henlius Brings In Abbott As Another Partner In Brazil

Chinese player Shanghai Henlius Biotech has out licensed semi-exclusive rights to some of its biosimilars in Brazil again, shortly after signing a major deal covering 16 Latin American countries.

Biosimilars Deals
See All

Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

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

ANI ‘On The Cusp Of A Transformation’ Following Cortrophin Launch

ANI Pharmaceuticals appeared confident about its Cortrophin gel launch and integration of Novitium Pharma as it rounded up its Q1 results, but net losses have dampened the company’s share value.

Sales & Earnings Launches

Accord Adds To Oncology Offering With Orgovyx

Accord Healthcare has struck a European licensing deal with Myovant Sciences for its Orgovyx (relugolix) treatment for advanced hormone-sensitive prostate cancer. The move comes shortly after sister company Accord Biopharma launched the Camcevi (leuprolide) prostate cancer treatment in the US.

Deals Strategy
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