Amgen launches AMGEVITA™ a biosimilar to adalimumab, in South Africa

First inflammation biosimilar from Amgen’s portfolio launches in South Africa


Johannesburg, Gauteng – Amgen recently launched a medicine used to treat autoimmune diseases in both adults and children.

AMGEVITA™ is a biosimilar medicine and contains the active substance adalimumab. This means that Amgevita is similar to the biological medicine that is authorised in South Africa.

It is available for patients suffering from the following conditions:

  • rheumatoid arthritis;
  • active ankylosing spondylitis;
  • severe axial spondyloarthritis – after an inadequate response to conventional therapy;
  • moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis;
  • psoriatic arthritis and moderate-to-severe chronic plaque psoriasis;
  • moderate-to-severe hidradenitis suppurativa;
  • non-infectious intermediate, posterior and panuveitis; or
  • polyarticular juvenile idiopathic arthritis.

AMGEVITA™, which is available in the country as of 23 April 2020, is the first adalimumab biosimilar to receive approval from the South African Health Products Regulatory Authority (SAHPRA).

The launch of AMGEVITA™ reflects Amgen’s commitment to developing high-quality biosimilars.


About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical needs and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and improve people’s lives. Amgen has grown to be one of the world’s largest independent biotechnology companies and is developing a pipeline of medicines with breakaway potential.

“Our company, a biotechnology pioneer since 1980 has grown to be one of the world’s leading independent biotechnology companies reaching millions of patients around the world. We are proud of the advances that we have made and will continue to put patients right at the centre of all our interventions and building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in South Africa. AMGEVITA™ is the first inflammation biosimilar to launch in the country and it will expand on the number of treatment options available to patients.” said  Dr Oscar Benyera, Head of Medical for Amgen South Africa.

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This medicine is available in a pre-filled syringe and pre-filled pen to support dosing recommendations for the different indications.

S4 – AMGEVITA 40 mg solution for injection in a pre-filled syringe. Each single-dose pre-filled syringe contains 40 mg of adalimumab in 0.8 ml (50 mg/ml) solution. Reg. No. 51/30.1/0678.

S4 – AMGEVITA 40 mg solution for injection in a pre-filled pen. Each single-dose pre-filled pen contains 40 mg of adalimumab in 0.8 ml (50 mg/ml) solution. Reg. No. 51/30.1/0678.

Full prescribing information available on request.


Amgen South Africa (Pty) Ltd., Co. Reg. No.: 2011/112148/07
Building D, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston Ext. 7, 2021
Tel: 011 100 5300 Fax: 011 100 5301 Adverse Event Reporting Fax: 0800 166 513