Six biosimilars have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use at its July meeting.

Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy Maxigesic IV in Brazil and the US.

After launching at the end of 2022, IBSA’s dedicated US authorized generics and complex generics unit, Yaral Pharma, has brought on board another of its parent company’s products.

Marketed as Bhava, Zydus’ bevacizumab rival to Roche’s Avastin begins the firm’s biosimilar journey in the Latin American country.

Brand-backed association the Alliance for Safe Biologic Medicines has expressed caution over FDA findings that bolster the case for biosimilar switching and suggest a reduction in the need for switching studies to support interchangeability.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

The IGBA has renewed calls to streamline biosimilar development by reducing comparative clinical studies and using the same comparator product across international jurisdictions, citing the findings of a recent publication by the International Pharmaceutical Regulators Programme’s Biosimilars Working Group.

Despite doubling down on its rare disease ambitions with its Alimera acquisition earlier in July, ANI just announced the second US launch of a generic this month.

The UK’s MHRA has approved the first generic raltegravir to treat HIV in adults and certain pediatric patients and deemed the drug interchangeable with the originator Isentress.

Endo continues to stride its financial revival path, with the latest plans to list common stock on the NYSE. Also, the firm has just launched a generic tiopronin rival to Travere Therapeutics' Thiola.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Despite doubling down on its rare disease ambitions with its Alimera acquisition earlier in July, ANI just announced the second US launch of a generic this month.

The UK’s MHRA has approved the first generic raltegravir to treat HIV in adults and certain pediatric patients and deemed the drug interchangeable with the originator Isentress.

Endo continues to stride its financial revival path, with the latest plans to list common stock on the NYSE. Also, the firm has just launched a generic tiopronin rival to Travere Therapeutics' Thiola.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

An additional week has been added to the deadline for companies to submit their entries for the Global Generics & Biosimilars Awards 2024, ahead of our ceremony in Milan on 9 October.

As she was re-elected as president of the European Commission, Ursula von der Leyen set out plans for the next European Commission that include a Critical Medicines Act to secure the supply chain.

Following on from a flurry of deal and launches, Hikma has released another product onto the US market with the first of its sodium acetate injections, bolstered by 180 days of Competitive Generic Therapy exclusivity. 

The latest UK generic pricing information from WaveData shows multiple products doubling or even trebling their average prices in June.

An FTC report has shown evidence of “troubling rebating practices” between pharma companies and PBMs, lowering access to generics and biosimilars. While off-patent groups commended the agency, the PBM association said the report falls short of being definitive or fact-based.

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Latvia’s Olainfarm has rebranded itself as Olpha, setting out its ambitions to become a top 10 pharmaceutical company in Europe and achieve turnover of “at least €1bn over the next ten years”.

Six biosimilars have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use at its July meeting.

Marketed as Bhava, Zydus’ bevacizumab rival to Roche’s Avastin begins the firm’s biosimilar journey in the Latin American country.

Just days after the first European ustekinumab biosimilar launch, Sandoz has entered the fray with the second rival to Stelara, introducing its Samsung Bioepis-partnered Pyzchiva version to compete with Stada and Alvotech’s Uzpruvo.

Boehringer Ingelheim is partnering with GoodRx in the US to offer a version of its Humira biosimilar at a 92% discount to the brand’s list price. Generics Bulletin spoke with Chris Marsh, Boehringer’s senior vice president of value and access, about the initiative.

Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy Maxigesic IV in Brazil and the US.

Marking the firm’s second launch of a 505(b)(2) injectable this year, Amneal has released Focinvez in the US as an antiemetic agent used in chemotherapy regimens.

An additional week has been added to the deadline for companies to submit their entries for the Global Generics & Biosimilars Awards 2024, ahead of our ceremony in Milan on 9 October.

Marking a further development in the story of Hyloris’ in-licensing deal with QliniQ, the company’s board has announced significant leadership and organizational changes to address potential concerns.

Six biosimilars have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use at its July meeting.

Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy Maxigesic IV in Brazil and the US.

After launching at the end of 2022, IBSA’s dedicated US authorized generics and complex generics unit, Yaral Pharma, has brought on board another of its parent company’s products.

Marketed as Bhava, Zydus’ bevacizumab rival to Roche’s Avastin begins the firm’s biosimilar journey in the Latin American country.

Just days after the first European ustekinumab biosimilar launch, Sandoz has entered the fray with the second rival to Stelara, introducing its Samsung Bioepis-partnered Pyzchiva version to compete with Stada and Alvotech’s Uzpruvo.

Despite doubling down on its rare disease ambitions with its Alimera acquisition earlier in July, ANI just announced the second US launch of a generic this month.

The UK’s MHRA has approved the first generic raltegravir to treat HIV in adults and certain pediatric patients and deemed the drug interchangeable with the originator Isentress.

Boehringer Ingelheim is partnering with GoodRx in the US to offer a version of its Humira biosimilar at a 92% discount to the brand’s list price. Generics Bulletin spoke with Chris Marsh, Boehringer’s senior vice president of value and access, about the initiative.

Endo continues to stride its financial revival path, with the latest plans to list common stock on the NYSE. Also, the firm has just launched a generic tiopronin rival to Travere Therapeutics' Thiola.

Samsung Bioepis has received US FDA approval for its Epysqli eculizumab biosimilar to Soliris, only the second version to be authorized in the US. However, the company declined to comment on launch plans as litigation with originator Alexion remains ongoing.

Brand-backed association the Alliance for Safe Biologic Medicines has expressed caution over FDA findings that bolster the case for biosimilar switching and suggest a reduction in the need for switching studies to support interchangeability.

Gedeon Richter has revealed that its European filing for a denosumab biosimilar rival to Prolia/Xgeva has been accepted for review by the EMA.