Biosimilars

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.

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.

Stada and Alvotech have heralded the start of biosimilar competition to Stelara in Europe with the launch of their partnered Uzpruvo version.

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.

One of the largest biologic opportunities for inflammatory bowel disorders, Johnson & Johnson’s Stelara, will open up to biosimilar competition in a matter of days, the originator has confirmed.

Sweden’s Xbrane Biopharma has delivered updates for two of its more long-term projects, including a proposed biosimilar to Bristol Myers Squibb’s Opdivo for which it is actively seeking a partner.

“The principles of fairness in procedural conduct, especially in commercial disputes, is crucial,” Delhi’s High Court told Zydus Lifesciences as it agreed to temporarily block the sale of the firm’s recently launched biosimilar to Roche’s Perjeta.

AI could help biosimilar developers with the development and manufacture of their products, but dependence on high-quality training datasets poses potential challenges.

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.