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.

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.

Fresenius Kabi has kicked off competition to Genentech’s Actemra in the US, launching its Tyenne biosimilar version of tocilizumab.

Following the drug’s earlier approval as a biosimilar to Prolia, China’s regulators greenlighted the use of Mabwell’s denosumab as a substitute for the second branded version, Xgeva, in its indications.

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.

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.

Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

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.

Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.

Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.

Lupin has claimed the first US approval for an Ingrezza generic – but must wait well over a decade before launching its version of valbenazine, after last year striking a patent litigation settlement with originator Neurocrine Biosciences.

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.

Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.

Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.

Lupin has claimed the first US approval for an Ingrezza generic – but must wait well over a decade before launching its version of valbenazine, after last year striking a patent litigation settlement with originator Neurocrine Biosciences.

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

Emerging out of its second Chapter 11 bankruptcy filing in the past four years, the company reported a slump in net sales despite positive signals in specific portfolios.

Hikma may have succeeded in dismissing Amarin’s induced infringement claim against the firm over Hikma’s skinny label generic Vascepa in the US, but a panel of judges for the US Court of Appeals for the Federal Circuit challenged that the generics manufacturer’s public disclosures “sound like an actual statement, encouraging use for the broad sweep of things: that this generic can be used instead of the brand, without any narrowing.”

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.

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

Lupin received a more than favorable backing from a US district judge in Delaware, as the court shot down Galderma’s arguments that the Indian firm’s ANDA product would infringe two of its US Oracea patents.

Tipped to bring in sales of $500m or more by 2030, Arcutis Biotherapeutics’ Zoryve 0.3% cream has become the target of an ANDA filed by Padagis, a partner of Sol-Gel Technologies. The originator responded with an immediate suit to shut down any potential generic launch in the near term.

Teva and Viatris hold firm ambitions in the long-acting schizophrenia space, and have just secured a win in their endeavors by convincing the US Court of Appeals for the Federal Circuit that a lower court erred in its analysis of whether a key Invega Sustenna patent was obvious.

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.

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.

Fresenius Kabi has kicked off competition to Genentech’s Actemra in the US, launching its Tyenne biosimilar version of tocilizumab.

Following the drug’s earlier approval as a biosimilar to Prolia, China’s regulators greenlighted the use of Mabwell’s denosumab as a substitute for the second branded version, Xgeva, in its indications.

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.

Teva has struck a $150m strategic development funding agreement with Abingworth and a clinical collaboration agreement with Launch Therapeutics to accelerate development of a dual-action asthma rescue inhaler.

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

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.

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.

Fresenius Kabi has kicked off competition to Genentech’s Actemra in the US, launching its Tyenne biosimilar version of tocilizumab.

Following the drug’s earlier approval as a biosimilar to Prolia, China’s regulators greenlighted the use of Mabwell’s denosumab as a substitute for the second branded version, Xgeva, in its indications.

Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.

Characterizing biosimilars as a global movement towards the democratization of medicine, Formycon CEO Stefan Glombitza speaks to Generics Bulletin in detail about the company’s recent deals, launches and key pipeline assets, in the first part of an exclusive two-part interview.

Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.

Switzerland and Canada mark the first market entries for Formycon’s ranibizumab biosimilar this year, with several anticipated launches in the Middle East later in 2024.

Lupin has claimed the first US approval for an Ingrezza generic – but must wait well over a decade before launching its version of valbenazine, after last year striking a patent litigation settlement with originator Neurocrine Biosciences.

Policy may be helpful in promoting acceptance of follow-ons in Medicare but is not expected to result in near-term savings to the program.

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

The rumor mill is heating up on Stada’s potential sale by its owners, Bain Capital and Cinven, after seven years at the helm.