The State of Biosimilars in 2023

by | Mar 17, 2023 | Focus, News

Introduction It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market.  While there have been challenges over this time, the U.S. biosimilar market has come a long way and...
Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo® (pegfilgrastim-bmez) / Nyvepria®(pegfilgrastim-apgf) / Fylnetra™ (pegfilgrastim-apgf) / Stimufend® (pegfilgrastim-fpgk)

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo® (pegfilgrastim-bmez) / Nyvepria®(pegfilgrastim-apgf) / Fylnetra™ (pegfilgrastim-apgf) / Stimufend® (pegfilgrastim-fpgk)

by | Feb 28, 2023 | News, Spotlight On

    Download PDF *Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs.  Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs are...
Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb) / Trazimera® (trastuzumab-qyyp) / Kanjinti® (trastuzumab-anns)

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb) / Trazimera® (trastuzumab-qyyp) / Kanjinti® (trastuzumab-anns)

by | Feb 28, 2023 | News, Spotlight On

      Download PDF *Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs.  Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs...

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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