Examples of Biosimilar in a sentence
Biosimilar drugs are manufactured after the patent and exclusivity protection of the BIOLOGIC drug have expired.
Biosimilar, interchangeable drugA U.S. FDA-approved biosimilar drug that may be automatically substituted for the original brand- name biologic drug.
Either Party shall, within *** Business Days, notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction.
If a Biosimilar Product to a Product is sold in any country in the Territory during the Product Royalty Term for such Product and country, the Product Royalties payable with respect to such Product in such country will be reduced by [***] for the remainder of such Product Royalty Term.
The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii).