Sam­sung and San­doz ques­tion FDA's 're­search roadmap' for biosim­i­lars de­vel­op­ment

The FDA last Jan­u­ary asked biosim­i­lar de­vel­op­ers and oth­er stake­hold­ers to com­ment on up­com­ing plans for new biosim­i­lar-re­lat­ed re­search. Over the last two weeks, biosim­i­lar de­vel­op­ers like Sam­sung Bioepis and San­doz, as well as in­dus­try groups sub­mit­ted ques­tions and chal­lenged the agency’s roadmap.

The roadmap, re­leased as part of the lat­est biosim­i­lar user fee deal from late last year, sought to es­tab­lish a re­search pi­lot pro­gram with two goals: to fur­ther the de­vel­op­ment of in­ter­change­able biosim­i­lars and to im­prove the ef­fi­cien­cy of biosim­i­lars de­vel­op­ment. The FDA al­so iden­ti­fied two ways to achieve those goals — in­creas­ing its ac­cu­ra­cy and ca­pac­i­ty for an­a­lyt­i­cal and CMC char­ac­ter­i­za­tions, and de­vel­op­ing al­ter­na­tives to re­duce the size of hu­man tri­als.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER