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Last week, PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz announced that they are entering into a research and development agreement to develop pembrolizumab, a biosimilar of Keytruda®, for the Brazilian Market.  According to the announcement, Bio-Manguinhos is a Brazilian government institution responsible for technology development and production of vaccines, reagents and biopharmaceuticals to meet public health needs, while PlantPraxis is a joint venture between PlantForm do Brasil (a wholly owned subsidiary of PlantForm Corporation) and Axis…
On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents. Yesterday, the parties filed a Joint Motion to Stay All Deadlines and Notice of Settlement.  The motion states that “[a]ll matters in controversy between the parties have been settled, in…
On March 26, 2021, the PTAB issued its Final Written Decision in Mylan Pharmaceuticals, Inc. v. Sanofi-Aventis Deutschland GMBH, IPR2019-01657, which involved Sanofi’s Patent RE47,614 (“’614 patent”) relating to its LANTUS (insulin glargine) product. The PTAB ruled in favor of Mylan and held all 18 claims invalid for obviousness in view of a combination of three references. The ’614 patent is a reissue of U.S. Patent No. 9,132,237.  The ’614 patent is directed to the…
In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and Innovation Act (BPCIA) and moderation in drug prices driven by market competition.  The white paper studied the price and volume of sales of 7 biologic drugs, namely NEUPOGEN (filgrastim), REMICADE (infliximab), EPOGEN (epoetin alfa), NEULASTA (pegfilgrastim), AVASTIN (bevacizumab), HERCEPTIN (trastuzumab), and RITUXAN (rituximab),…
At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties.  We previously reported back in February 2020 that Amgen sued Pfizer and its affiliate Hospira for patent infringement of U.S. Patent No. 8,273,707 (“’707 patent”) based on their proposed biosimilar of NEULASTA (pegfilgrastim). The ’707 patent claims processes for purifying proteins that require, among other limitations, using two specified salts “wherein the…
On April 5, 2021, Amneal Pharmaceuticals, Inc. (“Amneal”) and Kashiv BioSciences LLC (“Kashiv”) announced that Amneal’s wholly-owned subsidiary, Amneal Pharmaceuticals LLC, has completed its acquisition of a 98% interest in Kashiv’s wholly-owned subsidiary, Kashiv Specialty Pharmaceuticals, LLC (“Kashiv Specialty”).  According to the release, Amneal has a portfolio of more than 250 generic medicines and is expanding its portfolio to include complex dosage forms including biosimilars in a broad range of therapeutic areas, and Kashiv Specialty…
On March 25, 2021, biosimilar manufacturer mAbxience announced that it is expanding its León, Spain manufacturing facility with a new 4,000 L Custom Single Run (“CSR”) bioreactor.  mAbxience claims its León plant is “the biggest biologic plant in Spain and the first in Europe with fully integrated single-use technology in most processes.”  The new 4,000 L single-use bioreactor system is expected to be installed in the coming months, which, according to mAbxience, “will significantly increase…
Alteogen recently announced that it has successfully completed a Phase 1 clinical trial for its Eylea® biosimilar, ALT-L9.  Alteogen conducted the clinical trials in South Korea, where its headquarters are located.  In the clinical trials, ALT-L9 and Eylea® were randomly assigned to 28 patients with neovascular (wet) age-related macular degeneration (wet AMD).  Alteogen reported that its clinical trial results showed similar safety and efficacy between ALT-L9 and Eylea® which will support Alteogen’s phase 3 clinical trials…
In honor of Women’s History Month, Big Molecule Watch continues to highlight the work of women who have contributed to the advancement of biologics and biosimilars.  One such individual is Emer Cooke, who is the first woman to occupy the role of Executive Director of EMA and to lead that organization since its creation in 1994.  As we previously reported, Ms. Cooke took over this role in November 2020, in the midst of the…
On March 29, Samsung Bioepis announced the launch of its adalimumab biosimilar HadlimaTM, referencing AbbVie’s HumiraTM, in Australia in partnership with Merck & Co.  HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and plaque psoriasis.  In addition, on March 15, Samsung Bioepis launched its adalimumab biosimilar in Korea under the name AdalloceTM in partnership with Yuhan Corp.  Samsung…