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FDA generics approvals increasing but not for at-risk generics Generics/Research | Posted 29/11/2019

Analysis of generics approvals by the US Food and Drug Administration (FDA) reveals a slight increase in the total number of applications approved between 2016 and 2018. Over 1,800 applications wer...

Alvotech signs agreements with Stada and Yas Holding Pharma News | Posted 29/11/2019

Alvotech has entered into a strategic biosimilars collaboration with German company Stada. The company has also announced a significant investment from Abu Dhabi-based company Yas Holding for the e...

Concerns raised as Canada’s Alberta plans to switch patients to biosimilars Policies & Legislation | Posted 22/11/2019

Canada’s province of Alberta is planning to stop coverage of originator biologicals and switch patients to biosimilars for certain indications.

FDA approves adalimumab biosimilar Abrilada Biosimilars/News | Posted 22/11/2019

US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).

Varied approach to interchangeability across the MENA region Reports | Posted 22/11/2019

To achieve global agreement on issues of regulatory approval of biosimilars, open discussion across national borders and between different stakeholder groups is key. A lack of agreement between cou...

Qilu starts phase III trial for denosumab copy biological Biosimilars/News | Posted 22/11/2019

Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).

Brazilian efficacy and safety data for biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis Biosimilars/Research | Posted 22/11/2019

Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].

Lupin to sell its Japanese arm and Sandoz to acquire Aspen’s Japanese business Pharma News | Posted 22/11/2019

On 11 November 2019, India-based Lupin announced that it has agreed to sell its entire stake in its Japanese subsidiary Kyowa Pharmaceutical Industry Co to Japan-based private equity firm Unison Ca...