Pharma News
EMA authorizations: CRO generics suspended and Herceptin biosimilar refused
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has suspended the marketing authorizations of several generics medicines tested by Synchron Research Services on 20 May 2022. The committee also refused the marketing authorization for BioPharma’s Herceptin biosimilar, Tuznue, on 19 May 2022.
Lupin–Yabao partnership to bring paediatric medicines to China
In April 2022, global pharmaceutical company, Lupin announced that it has entered a strategic partnership with China’s Yabao Pharmaceutical Company. Together, the companies will work to meet the growing demand for quality drugs with paediatric formulations in Chinese markets.
Biosimilar Solutions to start trials of biosimilar filgrastim and GMP manufacturing
In late-March and mid-April 2022, Biosimilar Solutions Inc (Biosimilar Solutions) announced the start of its registrational clinical trials for BSC1020 and BSC0826 biosimilar filgrastim and on 14 March 2022, OcyonBio LLC (OcyonBio) announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions in Puerto Rico.
Aurobindo acquires Veritaz and Formycon–ATHOS partnership
In April 2022, Indian drugmaker, Aurobindo Pharma, acquired formulations business Veritaz. In addition, biosimilars specialist, Formycon, signed a partnership deal with ATHOS to merge development activities surrounding two biosimilars.
Fresenius Kabi acquire mAbxience and Ivenix
Fresenius Kabi is acquiring a majority stake in biosimilars company mAbxience, and is acquiring infusion pump maker, Ivenix outright. The deals are set to be completed by mid-2022.
Cipla–mAbxience partnership in South Africa
Cipla Medpro announced a partnership agreement with the global biotechnology company mAbxience in March 2022. This aims to provide essential oncology and respiratory-related biosimilars in South Africa.
Biocon to acquire biosimilars business from Viatris
India-based biologicals specialist Biocon Biologics (Biocon) announced on 28 February 2022 that it has entered into a definitive agreement with its partner Viatris (formerly Mylan) to acquire the latter’s biosimilar business.
Private equity firms poised to bid for Sandoz takeover
Following the late 2021 reports that Novartis is considering a possible sale or spinoff of its generics (and biosimilars) unit, Sandoz [1, 2], two private equity firms are now reportedly discussing a joint bid for the unit.
AbbVie and Alvotech settle Humira (adalimumab) disputes
US firm AbbVie and Iceland-based Alvotech have announced a resolution to the patent and trade secret disputes regarding Humira (adalimumab), for which Alvotech is developing a biosimilar.
Biogen and Xbrane form agreement for arthritis biosimilar
Biogen and Xbrane Biopharma (Xbrane) have announced a commercialization and licensing agreement for a biosimilar of certolizumab pegol (Cimzia), which can be used to treat rheumatoid arthritis and other inflammatory conditions.
