Pfizer, Novartis, BMS, and Novo Nordisk Lead Pipeline NewsBy
A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from Pfizer, Novartis, Roche, and Biogen.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 24, 2017 to Tuesday May 30, 2017.
FDA Advisory Committee Recommends for Approval Pfizer’s Biosimilar of Amgen’s Epogen
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a US FDA advisory committee, according to information from Pfizer.
The committee’s favorable recommendation was based on its review of the totality of evidence, including demonstration of comparable efficacy and safety of biosimilar epoetin alfa to its reference products, Amgen’s Epogen and Johnson & Johnson’s Procrit (epoetin alfa).
The company is seeking FDA approval of the following indications:treatment of anemia due to: chronic kidney disease\ in patients on dialysis and not on dialysis; zidovudine in HIV-infected patients; the effects of concomitant myelosuppressive chemotherapy, and upon initiation, a minimum of two additional months of planned chemotherapy; and reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, and nonvascular surgery.
The FDA will take the committee’s recommendation into consideration before taking action on the biologics license application for the proposed epoetin alfa biosimilar across all indications.
Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of its proposed epoetin alfa biosimilar in certain channels.
EMA Accepts Novartis’ Filings for Biosimilars of AbbVie’s Humira and J&J’s Remicade
The European Medicines Agency has accepted for review applications by Sandoz, the generics arm of Novartis, for proposed biosimilars of adalimumab (reference product, AbbVie’s Humira) and infliximab (reference product, Johnson & Johnson’s Remicade). Sandoz is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of the respective reference medicines, Humira and Remicade. Humira is AbbVie’s top-selling drug with 2016 sales of $16 billion, and Remicade is Johnson & Johnson’s top-selling pharmaceutical with 2016 sales of $6.97 billion.
These regulatory submissions follow soon after two positive opinions from an EMA advisory commitee for Sandoz biosimilars, etanercept and rituximab.The company said it is on track to launch five biosimilars of major oncology and immunology biologics, including adalimumab and infliximab, by 2020.
FDA Accepts for Priority Review New Use for BMS’ Opdivo
The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC. The FDA action date is September 24, 2017.
Opdivo is a blockbuster anti-cancer drug for BMS with 2016 sales of $3.77 billion. In the US, Opdivo is indicated for treating BRAF V600 mutation-positive unresectable or metastatic melanoma and BRAF V600 wild-type unresectable or metastatic melanoma as a single agent; unresectable or metastatic melanoma in combination with Yervoy (ipilimumab); metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; and locally advanced or metastatic urothelial carcinoma.
Source: Bristol-Myers Squibb
Novo Nordisk Submits Updated Label for Cardio Outcomes for Tresiba
Novo Nordisk has submitted a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba (insulin degludec) from a clinical trial to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care, in people with Type 2 diabetes.
Tresiba is a once-daily basal insulin that provides duration of action of at least 42 hours.
Source: Novo Nordisk