The results of a survey of board-certified rheumatologists in the United States about their beliefs and knowledge regarding biosimilar products were recently published in the journal Rheumatology. The online survey was conducted in May 2019 and included 19 multiple-choice questions assessing respondents’ knowledge of concepts and terminology concerning biosimilars, availability…
On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc. That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…
On July 29, 2020, Cadila Pharmaceuticals announced its launch of Rituximab biosimilar Ritucad for the Indian market. Rituximab is used to treat certain types of blood cancers and rheumatoid arthritis. Ritucad was the Indian pharmaceutical company’s second biosimilar launch in July. On July 22, 2020, Cadila announced the launch of…
Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical…
In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer. AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes…
Teva and Celltrion Healthcare announced today the U.S. launch of TRUXIMA® (rituximab-abbs) for rheumatoid arthritis (RA). TRUXIMA®, which originally launched in November 2019, is now approved to treat RA, non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyaniitis (MPA) in adult patients. …
On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals. At the PTAB, Pfizer had challenged the validity of Chugai’s patents (7,332,289 and 7,927,815) covering processes relevant to the manufacture of rituximab. In support…
On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars: Acellbia (rituximab), a biosimilar of Roche’s MabThera®, and Herticad (trastuzumab), a biosimilar of Roche’s Herceptin®. According to Biocad, the registration…
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices related to its cancer drugs. In the first investigation, the Competition Council found that between 2017 and 2019 Roche…
Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.” Bio-Thera indicated that…