JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL is pursuing as part of its strategic biologics alliance with Sanofi. According to the press…
We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental BLA to the FDA and an application for a variation to the marketing authorization to the EMA for XGEVA (denosumab). With these applications,…
Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab). BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. With the sBLA, Amgen seeks to add an indication for Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic…
In a press release, Roche announced today that FDA’s Oncologic Drug Advisory Committee has voted unanimously in favor of a subcutaneous injection of rituximab for the treatment of certain blood cancers, including previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular…
Today, AbbVie announced that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Fingernail psoriasis affects half of all psoriasis patients and HUMIRA is now the first-and-only biologic treatment with data on fingernail…
As we have previously reported, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief in support of Amgen. The 11 professors “teach and write on patent law and policy, and the economics of the biopharmaceutical industry,” and “are concerned with the…
Korean Biomedical Review is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly complete the development of” the product and “cooperate for its approval, production and marketing in China”. The article states…
FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug approved by the FDA for treatment of PPMS, which the CDC estimates affects 15% of patients with multiple sclerosis….
Sanofi and Regeneron announced yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. As we reported last week, Sanofi and Regeneron have filed…
As we previously reported, a number of amici curiae have submitted briefs in support of each party in Sandoz v. Amgen. On March 17, Biotechnology Innovation Organization (“BIO”), a trade association representing various members of the biotechnology industry, filed an amicus brief in support of Amgen. The brief argues that…