Alvotech and DKSH recently announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets. The press release does not name the biosimilar candidates, but states that they “address[] multiple therapeutic areas.” The companies previously entered into an exclusive license partnership for Alvotech’s adalimumab…
On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. According to Lotus’ press…
Today, Cadila Pharmaceuticals announced the launch of its adalimumab biosimilar, Cadalimab™, in India. HUMIRA® (adalimumab) is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis. Cadila’s press release noted that “[i]n an effort to strengthen their biosimilar product portfolio, Cadalimab™ is the fourth biosimilar launched in the last…
The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy. Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…
We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of its patents against biosimilar manufacturers to prevent the sale of biosimilar versions of Humira® (adalimumab) in the United States. On June 8, 2020, in a Memorandum and Opinion…
The Korean Herald reported today that Celltrion has applied for the European Medicine Agency’s approval of CT-P17, a Humira (adaliumumab) biosimilar. According to the Korean Herald, Celltrion “expects to introduce CT-P17 to the European market in about a year’s time, which is how long the EMA typically takes to review.” …
On Feb. 13, 2020, the European Medicines Agency (EMA) granted market authorization for Amsparity, Pfizer’s adalimumab biosimilar. Amsparity is approved for use in treating the same set of conditions as Humira in Europe. In 2018, Pfizer announced that it had reached a license agreement with AbbVie that allowed Pfizer to…
Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody™ to discover multiple novel bispecific antibodies.” This…
On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar approved by the NMPA and has been approved for the treatment of three autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and plaque…
As we previously reported, AbbVie had appealed the PTAB’s final written decisions that the challenged claims of U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987, directed to methods of using adalimumab, are unpatentable on obviousness grounds. These final written decisions stemmed from IPR petitions filed by Coherus against all three patents,…