Mylan, Amgen & Allergan, and Pfizer Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Mylan, Pfizer, and Gilead Sciences.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, July 19, 2017 to Tuesday, July 25, 2017.

Mylan Advances Biosimilar of Roche Blockbuster Drug

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee has recommended for approval a proposed biosimilar to Roche’s cancer drug Herceptin (trastuzumab) from Mylan and Biocon, a Bangalore, India-based biopharmaceutical company. Herceptin is a top-selling drug for Roche with 2016 sales of CHF 6.78 billion ($7.04 billion).

The FDA advisory committee voted in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings. The FDA uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals. The FDA often follows the advice of advisory committees in determining whether a product should come to market although they are not required to follow it.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products being co-developed by Mylan and Biocon. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand, and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Mylan and Biocon’s proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe, and several emerging markets.

Source: Mylan


Amgen, Allergan Advance Biosimilar of Roche Cancer Drug
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee has recommended for approval a proposed biosimilar from Amgen and Allergan to Roche’s cancer drug, Avastin (bevacizumab). Avastin is one of Rohe’s top-selling drugs with 2016 global sales of CHF 6.78 billion ($7.04 billion).

The FDA uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals. The FDA often follows the advice of advisory committees in determining whether a product should come to market although they are not required to follow it. The FDA has set a Biosimilar User Fee Act target action date of September 14, 2017.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Under the agreement, Amgen has primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.

Amgen has a total of 10 biosimilars in its portfolio, one which has been approved by the FDA. In September 2016, Amgen received FDA approval for Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab), AbbVie’s anti tumor necrosis factor (TNF) monoclonal antibody that is approved for multiple indications. Amjevita has been approved for treating seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. Humira was AbbVie’s top selling drug in 2016 with global sales of $16.08 billion.

Source: FDA Oncologic Drugs Advisory Committee (July 13, 2017 meeting, webcast)


FDA Accepts Pfizer’s sNDA for New Use for Anti-inflammatory Drug
The US Food and Drug Administration (FDA) has accepted for filing a supplemental new drug application (sNDA) for Pfizer’s Xeljanz (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis.

The FDA has provided an anticipated Prescription Drug User Fee Act action date in March 2018 for the sNDA.

Source: Pfizer


EMA Validates Filing for Gilead’s HIV Combo Therapy
The European Medicines Agency (EMA) has validated and is now evaluating the marketing authorization application for Gilead Sciences’ once-daily single tablet regimen containing bictegravir (50 mg; BIC), an investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25mg; FTC/TAF) for treating HIV-1 infection in adults.

The BIC/FTC/TAF filing will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union as well as Norway and Iceland.

Gilead submitted a new drug application for BIC/FTC/TAF in the US in June 2017.

Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment and is not yet approved anywhere globally.

Source: Gilead Sciences

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