The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…
Second Biosimilar Equivalent to Adalimumab
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…