Celltrion has received a positive opinion from the CHMP for five additional indications for its Remsima SC biosimilar, expanding the scope of the subcutaneous infliximab product that was launched earlier this year.
Celltrion will be able to expand the scope of treatment for its innovative subcutaneous formulation of biosimilar infliximab after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending an additional five indications for Remsima SC, including for use in inflammatory bowel disease and ankylosing spondylitis.
The European Commission typically acts to convert CHMP recommendations into formal approvals within 67 days.
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.
Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.
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.
Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.
Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.
