Biosimilars
Stada in-licenses teriparatide biosimilar
German generics giant Stada Arzneimittel (Stada) announced on 13 October 2014 that it had made a deal to in-licensing a teriparatide biosimilar.
Phase III study of biosimilar adalimumab meets primary endpoint
Biologicals major Amgen announced on 8 October 2014 the first late-stage data from its biosimilars programme. Primary efficacy analysis from a phase III trial of Amgen’s adalimumab biosimilar (ABP 501) compared with Humira (adalimumab) has demonstrated ‘clinical equivalence’.
Merck KGaA plans further investment in biosimilars
German pharma giant Merck KGaA announced on 18 September 2014 plans to step up investments in biosimilars during 2015.
Epirus and Livzon collaborate on copy biologicals for China
US-based Epirus Biopharmaceuticals (Epirus) announced on 25 September 2014 that it had signed a collaboration agreement with Chinese biotechnology company Livzon Mabpharm (Livzon).
Infliximab ‘similar biologic’ receives Indian approval
US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 15 September 2014 that it had received final marketing and manufacturing approvals for its infliximab similar biologic, BOW015, from the Drug Controller General of India (DCGI).
Biosimilars of adalimumab
Last update: 11 March 2024
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
Mylan starts phase III trials for biosimilar insulin glargine
Generics maker Mylan has started two US phase III clinical trials for a biosimilar version of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).
IAPO releases toolkit for biologicals and biosimilars
The International Alliance of Patients’ Organizations (IAPO), which comprises over 200 patient groups and represents the interests of patients worldwide, has published an Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations. The Toolkit, published in November 2013, provides up-to-date, evidence-based information on the science, technology and regulatory information relevant to biologicals and biosimilars.
Call for action on labelling of biosimilars
European trade association, the European Association for Bioindustry (EuropaBio) has called on the European Medicines Agency (EMA) to define specific guidance on the labelling of biosimilars.
Amgen starts phase III trial for biosimilar rituximab
Biologicals major Amgen is carrying out a global phase III clinical trial for a biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).
