Cigna’s Evernorth has announced plans to make a Humira biosimilar available for $0 out-of-pocket for Accredo patients from June, adding to momentum for adalimumab rivals from previous policy changes made by CVS in recent weeks. Meanwhile, AbbVie has offered the latest on how competition to its once top-selling brand is ramping up.

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.

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 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.

In the second part of an exclusive interview, Formycon CEO Stefan Glombitza talks to Generics Bulletin about key regulatory developments in Europe and the US, the firm’s portfolio selection strategy, and upcoming milestones on the horizon.

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

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.

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.

Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a firefighters’ pension fund accused the firm of misleading investors via its involvement in generic price fixing, leading to a fall in the price of its securities.

Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health’s core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label.

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.

Cigna’s Evernorth has announced plans to make a Humira biosimilar available for $0 out-of-pocket for Accredo patients from June, adding to momentum for adalimumab rivals from previous policy changes made by CVS in recent weeks. Meanwhile, AbbVie has offered the latest on how competition to its once top-selling brand is ramping up.

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.

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.

At the latest meeting of the EMA’s CHMP committee, the agency recommended that Amgen be granted a third European marketing authorization for a Stelara biosimilar.

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.

One down, two more to go. Celltrion seals a formulary deal with one of the top three PBMs in the US for its subcutaneous infliximab product Zymfentra.

Cigna’s Evernorth has announced plans to make a Humira biosimilar available for $0 out-of-pocket for Accredo patients from June, adding to momentum for adalimumab rivals from previous policy changes made by CVS in recent weeks. Meanwhile, AbbVie has offered the latest on how competition to its once top-selling brand is ramping up.

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.

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.

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.

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.

At the latest meeting of the EMA’s CHMP committee, the agency recommended that Amgen be granted a third European marketing authorization for a Stelara biosimilar.

It’s been a year since Biogen made it clear that it was ready to put its biosimilars business on the market. But despite signaling interest in the unit from multiple potential suitors over the past 12 months, the firm says it hasn’t yet received any “acceptable” offers, and may retain it after all.

Ahead of the EMA’s CHMP publishing its April meeting highlights, Biogen has revealed a positive opinion for its Tofidence biosimilar tocilizumab rival to RoActemra. However, Fresenius already has a version on the market.

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.