What is biosimilar Ranibizumab?

Ranibizumab is a medicine that is injected into the eye. It is used to treat eye conditions which affect the retina, such as wet age-related macular degeneration and diabetic eye conditions. It belongs to a group of medicines called anti-vascular endothelial growth factor (Anti-VEGF) agents.

Ranibizumab is a biological medicine which means it is made or derived from living cells. Biosimilar Ranibizumab is a highly similar copy of the original Ranibizumab medicine. A biosimilar is a medicine that is similar in quality, safety, and effectiveness to the original licensed medicine. 

How does it work?

If you are receiving treatment or have been recommended treatment with Ranibizumab by your ophthalmic healthcare professional, your eye contains excessive amounts of a substance called vascular endothelial growth factor (VEGF). Too much VEGF causes leaky, abnormal blood vessels.

The excess fluid that comes from these blood vessels can build up in your eye and affect your vision by causing swelling and eventually scarring in your retina.

Ranibizumab blocks the action of VEGF. This prevents abnormal blood vessels from growing and stops damaged blood vessels from leaking fluid. Regular treatment with Ranibizumab may be necessary to stabilise your vision and prevent loss of vision. 

How is it administered?

Ranibizumab is given as a course of injections into the eye lying down in the injection room under local anaesthetic.

Your ophthalmic healthcare professional will advise on the number and frequency of injections you need.  

Are biosimilars safe?

All medicines in the UK including biosimilar medicinal products undergo rigorous tests for quality, biological activity, safety, and effectiveness.  

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a licence for the use of biosimilars. The MHRA is a regulatory body for medicines in the UK who authorises and maintains, laws and policies required to ensure that medicines are safe and effective for use. Licences by the MHRA are granted only if the quality and safety standards are met. 

The National Institute for Health and Care Excellence (NICE) is an independent public body who provides guidance, quality standards, advice and information services for health, public health, and social care. If NICE recommends the original biological medicine in their guidance, the same recommendation applies to the biosimilar medicines.  

Biosimilar Ranibizumab benefits

Biosimilars offer the same clinical effectiveness and safety as the original product e.g. Ranibizumab Lucentis®, but at a lower cost.

Risks and side-effects

All versions of the drug Ranibizumab can cause similar side effects. If you experience any problems with your treatment, report it promptly to your ophthalmologist.   

Some common side effects that could occur include:  

  • Red eye (there is usually a bleed or bruise on the white part of the eye at the site of injection, which clears in a week or two).  
  • Sore and gritty eye (slight ache and discomfort lasting a day or two).  
  • ‘Blobs’ or small specks in your vision (‘floaters’) might be seen for a few days after the injection. You may also experience transient flashing lights or swirls of light immediately after the injection. 

Switching to biosimilar Ranibizumab

When you arrive to your next injection appointment, you will be seen by a clinician who will provide you with all the necessary and important information relating to your injection treatment of a biosimilar Ranibizumab Ongavia®. 

The process of administering Ongavia® is the same as all the other anti-VEGF intravitreal injections. However, Ongavia® requires preparation prior to administration as the solution is presented in a vial. The injections will continue to be delivered by ophthalmologists, highly trained specialist ophthalmic nurses and practitioners. 

There will be an opportunity to discuss any concerns or questions you may have. The consultation with the ophthalmologist will help you to make an informed decision prior to signing the consent form for the continuation of your treatment using Ongavia®  

Biosimilar Ranibizumab alternatives

Other anti-VEGF agents include Aflibercept (Eylea®), Brolucizumab (Beovu®), Bevacizumab (Avastin®) and Faricimab (Vabysmo®). Your ophthalmic healthcare professional will have discussed your treatment options with you and advised which medicine is best for your condition.  

What versions of Ranizumab are available in the UK?

Until recently, only one pharmaceutical company made Ranibizumab. Now, other companies make biosimilar versions of Ranibizumab and these have become available; the biosimilar of choice for the Royal Free London NHS Foundation Trust is known as Ongavia®. New forms of Ranibizumab are now being used throughout the UK to treat patients with retinal conditions.