Posted in:News Pfizer Challenges Another Herceptin® Patent With Two New IPR Petitions By C. Nichole Gifford July 11, 2017 Comments are off On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897... Read more Tagged with: Genentech, Herceptin®, Hospira, IPR, Legal, News, Pfizer, PTAB, Roche, trastuzumab, USPTO http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Celltrion’s Application for Rituxan® (rituximab) Biosimilar Accepted by FDA By C. Nichole Gifford July 3, 2017 Comments are off Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s... Read more Tagged with: Biogen, Celltrion, FDA, Genentech, News, Regulatory, Rituxan®, Rituximab, Teva http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Sandoz’s Rixathon® (rituximab) Approved in Europe By Andrew Storaska June 29, 2017 Comments are off On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s... Read more Tagged with: EMA, FDA, Genentech, Mabthera, News, Regulatory, Rituxan®, Rituximab, Rixathon®, Sandoz http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News FDA Unexpectedly Rejects Pfizer’s Application for an Epoetin Alfa Biosimilar (Again) By C. Nichole Gifford June 28, 2017 Comments are off We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended... Read more Tagged with: Amgen, epoetin alfa, Epogen®, FDA, Hospira, News, Pfizer, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Samsung Bioepis’ Imraldi® (adalimumab) Recommended for Approval in Europe By C. Nichole Gifford June 26, 2017 Comments are off On June 22, 2017, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicine’s Agency (“EMA”)... Read more Tagged with: AbbVie, adalimumab, Biogen, EMA, FDA, Humira®, Imraldi®, News, Regulatory, Samsung Bioepsis http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Fujifilm Kyowa Kirin Biologics Announces Application for Humira® (Adalimumab) Biosimilar Accepted by EMA By C. Nichole Gifford June 8, 2017 Comments are off Fujifilm Kyowa Kirin Biologics announced that its Medical Marketing Application (“MMA”) for FKB327, a biosimilar to AbbVie’s Humira®... Read more Tagged with: AbbVie, adalimumab, AstraZeneca, Avastin®, bevacizumab, EMA, FDA, Fujifilm Kyowa Kirin, Humira®, News, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News FDA Advisory Committee Meeting Announced for Amgen’s and Allergan’s Proposed Biosimilar to Avastin® (Bevacizumab) By C. Nichole Gifford June 8, 2017 Comments are off The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215,... Read more Tagged with: Allergan, Amgen, Avastin®, bevacizumab, FDA, Genentech, News, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus