The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars business grow by more than a tenth.

Lupin has pushed into the Canadian biosimilars market with the launch of its Rymti rival to Amgen’s Enbrel. The launch is taking place via Lupin’s local partner Sandoz.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss whether transatlantic convergence is possible or merely a good idea on paper.

The approval brings another biosimilar to Amgen’s Neulasta, stepping up competition in an already heated market that has seen major approvals in the past year.

The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss whether transatlantic convergence is possible or merely a good idea on paper.

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Hikma will look to guarantee US generic competition to the powerful opioid brand Nucynta, albeit in the form of an authorized generic, as questions swirl over the appetite of at least one ANDA filer to compete on an equal footing, per the terms of a patent-litigation settlement deal.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss whether transatlantic convergence is possible or merely a good idea on paper.

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Hikma will look to guarantee US generic competition to the powerful opioid brand Nucynta, albeit in the form of an authorized generic, as questions swirl over the appetite of at least one ANDA filer to compete on an equal footing, per the terms of a patent-litigation settlement deal.

With Teva and Viatris recently under new management and Sandoz having last year split from former parent company Novartis, the three off-patent industry leaders are adopting different strategies for how they balance their generics and biosimilars interests with more innovative ventures. Generics Bulletin takes a look at the bigger picture.

India’s Biocon Limited has struck an exclusive deal for a generic version of semaglutide in Brazil with local player Biomm. And a recent court ruling means that launch could come sooner rather than later for the Ozempic rival.

With 80% of medicines used by the UK’s National Health Service being off-patent drugs, the UK is nevertheless in need of a new economic framework to save waning competition due to low prices, delegates to a Westminster Health Forum conference heard from a Sandoz executive.

Vanda looks likely to have to face up to unimpeded US generic competition to its core Hetlioz brand, after a further denial in its litigation against ANDA sponsors Teva and Apotex.

After the drug’s approval for use in neuropathic pain within the EU last December, Adalvo announced the analgesic’s first European launch in Germany.

The FDA’s Drug Shortage Staff said it aims to resolve long-term, not just short-term, issues with drug supplies, as the country sees the highest-ever levels of drug shortages.

Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.

Sandoz has fired a defensive shot in a US court against the potential that it may have to fork up higher rebates for two of its drugs via the Centers for Medicare & Medicaid Services’ Medicaid drug rebate program – six years after the suggestion was first made.

Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars business grow by more than a tenth.

Lupin has pushed into the Canadian biosimilars market with the launch of its Rymti rival to Amgen’s Enbrel. The launch is taking place via Lupin’s local partner Sandoz.

Celltrion unveils its agreement with the PBM Express Scripts that will place its Zymfentra subcutaneous infliximab on its preferred formulary after alluding to the deal in an earlier notice. 

The US FDA has marked a milestone with the approval of the country’s 50th biosimilar, in the form of Henlius and Accord BioPharma’s Hercessi trastuzumab rival to Herceptin.

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Amneal launched two highly anticipated products, a ready-to-use pemetrexed injectable Pemrydi and over-the-counter naloxone spray, strengthening the firm’s focus on injectables and inhalation.

After the drug’s approval for use in neuropathic pain within the EU last December, Adalvo announced the analgesic’s first European launch in Germany.

Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars business grow by more than a tenth.

Lupin has pushed into the Canadian biosimilars market with the launch of its Rymti rival to Amgen’s Enbrel. The launch is taking place via Lupin’s local partner Sandoz.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss whether transatlantic convergence is possible or merely a good idea on paper.

Generics Bulletin reports on some of the most noteworthy and important appointments affecting the global generics and biosimilar industries.

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.

Celltrion unveils its agreement with the PBM Express Scripts that will place its Zymfentra subcutaneous infliximab on its preferred formulary after alluding to the deal in an earlier notice. 

The US FDA has marked a milestone with the approval of the country’s 50th biosimilar, in the form of Henlius and Accord BioPharma’s Hercessi trastuzumab rival to Herceptin.

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Teva and Alvotech have confirmed deductions that it is their recently-approved 100mg/ml adalimumab biosimilar that will be used by Cigna’s Evernorth as part of a recently announced private-label deal involving Evernorth’s Quallent Pharmaceuticals.

Formycon has shared its results for 2023, reporting revenue growth and exceeding projections for its working capital, as the company prepares for approvals in the coming year.