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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.
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.
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.
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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.
Commercial Explore this Topic
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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.
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.
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.
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.
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.
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.
Policy & Regulation Explore this Topic
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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.
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.
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.
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.
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.
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.
Generic Drugs Explore this Topic
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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.
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.
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.
Biosimilars Explore this Topic
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Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
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.
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.
Value-Added Medicines Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
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.
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.
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