Oncology

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

The Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015.

Ireland’s National Cancer Control Programme (NCCP) has issued new guidance on the use of biosimilar medicines in the treatment of cancer.

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.

Robert Cerwinski, JD, Partner at Goodwin, discusses the “big 3” biologics for inter partes review: Herceptin, Rituxan, and Humira.

Genentech, a member of the Roche Group, announced on Sunday that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted a priority review for the company’s obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for patients who have previously untreated follicular lymphoma.

Providing prophylactic treatment with granulocyte-colony stimulating factor to patients receiving chemotherapy may yield better chemotherapy-induced neutropenia, febrile neutropenia, and related hospitalization outcomes if patients receive prophylaxis at levels above guideline recommendations, according to a recent study.

Recombinant human granulocyte colony-stimulating factor (G-CSF), filgrastim, and its long-acting pegylated form, pegfilgrastim, are widely used to reduce the risk of chemotherapy-induced neutropenia, but to date, no pegfilgrastim biosimilar has been approved in highly regulated markets such as Europe, Japan, and the United States.

Yesterday, Biocon withdrew from the European Medicines Agency (EMA) its applications for the authorization of biosimilar trastuzumab and pegfilgrastim.

Treatment guidelines for ovarian and cervical cancer recommend the use of the angiogenesis inhibitor bevacizumab (Avastin), but patient access to this medication and other angiogenesis inhibitors is limited.