Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards. WHO prequalification status is based on an assessment of the quality, safety, and efficacy of a medicine and enables the recipient to participate in UN procurement tenders. Herzuma has been commercially available in Europe since May 2018,…
As we previously reported, Genentech and JHL Biotech reached a settlement agreement resolving the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products. However, the case continued against the four former Genentech employees as individual defendants, although…
On July 23, 2020, Centus Biotherapeutics received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for EQUIDACENT, a biosimilar to AVASTIN (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer,…
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…
Yesterday, India-based Cadila Pharmaceuticals announced the launch of its bevacizumab biosimilar for the Indian market under the brand name BEVARO. Bevacizumab is a biosimilar of Genentech’s AVASTIN and is indicated for the treatment of multiple cancers, including ovarian cancer, glioblastoma multiforme, colorectal cancer, breast cancer, lung cancer, cervical cancer, and…
Samsung Biologics has announced that it may expand its manufacturing capacity at its site in Songdo, Incheon. Launched in 2011, Samsung has three plants housing a total of 364,000 L of mostly stainless-steel bioreactor capacity that, according to Samsung’s CEO, will be fully utilized to capacity by 2022. Samsung’s CEO…
Last week, the EMA authorized Insulin aspart Sanofi’s biosimilar product. The EMA notes on its website that Insulin aspart Sanofi is “highly similar to another biological medicine [NovoRapid] that is already authorized in the EU.” Insulin aspart Sanofi contains the active substance insulin aspart, a rapid-acting insulin, and received marketing…
We have previously reported that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, are combining to form a new company. We also reported that although the planned integration has been delayed because of the COVID-19 pandemic, the transaction is expected to close in the second half of 2020. 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 previously reported on an International Trade Commission hearing in a trade secret dispute brought by Allergan and Medytox against Daewoong and Evolus. In the underlying investigation, Allergan and Medytox seek to block importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection). A one-page public…