A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Novartis, Pfizer, and Otsuka Pharmaceuticals.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, May 30, 2018 to Tuesday, June 5, 2018.

EMA Advisory Committee Recommends Three Novartis’ Biosimilars and Pfizer Biosimilar
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for four biosimilars: three biosimilars from Sandoz, the generics arm of Novartis, which reference AbbVie’s Humira (adalimumab), and one biosimilar from Pfizer, which references Roche’s Herceptin (trastuzumab. Humira had 2017 global sales of $18.43 billion, and Herceptin had 2017 global sales of CHF 7.01 billion ($7.5 billion).

The CHMP recommended approval of Sandoz’s adalimumab biosimilar under three brand names,  Halimatoz, Hefiya and Hyrimoz, for treating certain inflammatory and autoimmune disorders. The CHMP opinion recommends Sandoz’s biosimilar for treatment of all indications of the reference medicine, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

If approved, the European Commission (EC) would grant a centralized marketing authorization that will be valid in the 28 countries that are members of the European Union. Norway, Iceland, and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions based on the EC’s recommendation.

Other companies have received EU approval for biosimilars of adalimumab. Boehringer Ingelheim received EU approval for Cyltezo (adalimumab-adbm), a Humira biosimilar, in August 2017. Also in August 2017, Samsung Bioepis, a joint venture between Samsung BioLogics, an Incheon, South Korea-based contract biologics manufacturer, and Biogen, received approval on its adalimumab biosimilar,  Imraldi. Amgen received EU approval for Amgevita in March 2017.

Earlier this year (April 2018), AbbVie had announced a patent settlement with Samsung Bioepsis, delaying the launch of Imraldi until June 2023 in the US. A similar deal was made with Amgen in September 2017 for the launch of Amgevita in the US, which has been delayed until January 2023. Both companies in their deals with AbbVie, however, are allowed to launch biosimilars in Europe beginning in October 2018 (October 16, 2018). 

The CHMP has also recommended for approval Pfizer’s Trazimera (trastuzumab), for treating breast and gastric cancer, as a biosimilar to Roche’s Herceptin. Trazimera is Pfizer’s fourth biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA. Pfizer’s biosimilars pipeline consists of 11 biosimilar molecules in various stages of development.

Source: Novartis and Pfizer

EMA Advisory Committee Recommends Novartis’ Potential Blockbuster, Otsuka’s Schizophrenia Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Novartis’ and Amgen’s Aimovig (erenumab), a potential blockbuster drug for treating migraines, and Otsuka Pharmaceutical’s schizophrenia drug.

Aimovig belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks, according to the EMA. Novartis identifies Aimovig as a potential blockbuster drug. Aimovig is expected to reach blockbuster status in 2022 with sales of $1.170 billion, according to a recent analysis by Clarivate Analytics.

The US Food and Drug Administration (FDA) approved Novartis’ and Amgen’s Aimovig in May 2018.

The committee has also recommended Otsuka Pharmaceutical’s Rxulti (brexpiprazole), for treating schizophrenia.

Source: EMA