Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.
The US Food and Drug Administration has approved Boehringer Ingelheim’s higher-concentration formulation of its Humira (adalimumab) biosimilar Cyltezo – but without granting it a coveted interchangeability designation, in an increasingly heated market.
While the company’s previously approved lower-concentration Cyltezo formulation was the first Humira biosimilar to receive the designation of interchangeability, the...
Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.
Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.
Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.
Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.
Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.
