As we have previously reported, on June 12, 2017, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz holding that notice of commercial marketing may be given prior to FDA approval. The Court also held that no injunction is available under federal law to force compliance with the…
Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan® (rituximab). Rituxan® (marketed as MabThera® in the EU) is approved for the treatment of non-Hodgkin’s…
The FDA announced that it is soliciting public comments on the statement of work for the assessment of its proposed new model for the review of original Biologics License Applications submitted under section 351(k) of the Public Health Service Act. Last fall, we reported on the FDA’s performance goals for the reauthorization…
Yesterday, RAPS reported that the FDA is expecting the first interchangeable biosimilars to become available in the U.S. market within the next two years. Interchangeable biosimilars are those that “can be expected to produce the same clinical result as the reference product in any given patient.” In states with automatic substitution…
On Wednesday, June 28, 2017, at 12:00 PM EST, Goodwin will host a webinar discussing the Supreme Court’s Decision in Sandoz v. Amgen. On June 12, the Supreme Court decided Sandoz v. Amgen, which presented the Justices with multiple significant questions about the correct interpretation and application of the biosimilars…
As reported by Money News, Cipla Ltd., India’s fifth-largest drugmaker by sales, plans to reduce investment in biosimilars to sharpen its focus on building a portfolio of high-margin respiratory products. Cipla’s original plan to build a biotech plant in South Africa has been put on hold. Cipla’s CEO, Umang Vohra, states…
According to a Biogen press release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Biogen’s Imraldi®, a proposed biosimilar to AbbVie’s Humira® (adalimumab). The Imraldi application was submitted to the EMA by Samsung Bioepis, a joint venture between Biogen and Samsung…
According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha). Pfizer said the CRL relates “to matters noted in a Warning Letter issued on February…
On June 6, 2017, Biocad, a Russia biotechnology company, announced that it has obtained marketing authorization for its rituximab biosimilar in Bolivia and Honduras under the trade name USMAL, and that shipments will start in the beginning of Q3 2017. Biocad further stated that it is registering its rituximab biosimilar…
PlantForm Corporation, a Canadian biotech firm, has announced that it will begin construction this summer on a new biopharmaceutical lab in Rio de Janeiro with its partner, Brazil-based Axis Biotec Brasil. According to PlantForm’s press release, the joint venture, known as PlantPraxis, “will first develop a biosimilar version of adalimumab (Humira®)…