Confusion Persists Over US Biosimilar Interchangeability
Urgent Need For Clarity Over Misperceptions Linked To Unique US Designation, Paper Insists
The US biosimilars industry is being constrained by misunderstandings stemming from the country’s interchangeability designation, a new paper in BioDrugs has highlighted, citing an urgent need for clarity over the misperception that interchangeable biosimilars are superior to biosimilars without the designation.
You may also be interested in...
Generics Bulletin sits down with Biosimilars Forum executive director Julie Reed to discuss preparing the HHS for Humira biosimilars, what more the agency could do for the industry and the Forum’s priorities over the next year.
Following decisions by the EMA’s CHMP to deny Prestige Biopharma a marketing authorization for its trastuzumab biosimilar and to suspend the marketing authorizations of dozens of generics due to concerns over bioequivalence tests, the European regulator has confirmed it will review the opinions.
Dr Reddy’s is in line for a $72m payout after settling US patent and antitrust litigation over Suboxone with Indivior.