Tag Archives: biosimilar

Use of Abasaglar (Biosimilar Insulin Glargine)

The patent for Lantus® (Insulin glargine) has expired and a biosimilar preparation called Abasaglar®, which has a lower cost, has been launched. It has yet to be considered in the Local medicines decision making process, guidance for use with defined patient criteria is pending.

NB: The administration devices for Lantus and Abasaglar are slightly different. Lantus uses the Solostar pen, and Abasaglar the Kwikpen device.

Existing patients should continue to receive Lantus.  Patients should not be routinely switched between brands.

Automatic substitution, defined here as the practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber is not appropriate for biological medicines, including biosimilar medicines and is not permitted at this time. Prescribers, of course, are always able to switch treatments for a given patient, provided it is safe to do so and there are appropriate monitoring arrangements in place.

As biosimilar medicines often use the same international non-proprietary name (INN) as their reference product, the main way to ensure automatic substitution does not take place is through brand name prescribing. Brand name prescribing should be adhered to by all prescribers for biological medicines, including biosimilar medicines, and is in line with recommendations from the MHRA and NICE, as well as being enshrined in EU law.

Prescribing

It is essential that patients stay on the same brand. All prescribing should be by Brand Name as recommended in local prescribing guidance for all insulin prescribing.
In primary care we recommend that all practices search for any patients currently prescribed insulin glargine generically and change to the existing branded product, Lantus® before Abasaglar® becomes more widely available, to avoid later confusion.

Dispensing

Pharmacists should dispense the brand ordered and not substitute. If a brand is not specified the prescription needs to be returned to the prescriber for this to be added.
Please note that pharmacists will not dispense insulin glargine unless prescribed by brand as they are not authorised to amend prescriptions.

Administration/ record keeping

It is important that a record is kept within the patient’s notes of the brand used. This is to facilitate reporting of adverse effects.

Adverse reactions (whether suspected or established) should be documented on Yellow Card reports to the MHRA as previously.

Biosimilars – NICE resource to support the implementation of biosimilar versions of infliximab

NICE has published a new adoption resource to support the introduction of biosimilar versions of infliximab: Inflectra and Remsima.  This resource has been developed for both clinical and non-clinical staff to help them manage the introduction of these biosimilar medicines into their care pathways safely and effectively. It will be particularly relevant and useful to gastroenterology; rheumatology, pharmacy and nursing staff, as well as to other clinical areas that are planning for the introduction of biosimilar medicines and their commissioners.

Message from NICE

A biosimilar medicine is a biological medicine that is developed to be highly similar to an existing biological medicine in physicochemical and biological terms. NICE’s position statement on evaluating biosimilar medicines was published in January 2015. This states that biosimilars notified to the NICE topic selection process for referral to the Technology Appraisal programme will usually be considered in the context of a Multiple Technology Appraisal, in parallel with their reference products in the indication under consideration. The Department of Health has confirmed that a technology appraisal remit referred to NICE enables NICE to decide to apply the same remit, and the resulting guidance, to relevant licensed biosimilar products which subsequently appear on the market.

Infliximab is used to treat a number of autoimmune and inflammatory disorders, including: adult rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis, and adult and paediatric Crohn’s disease and ulcerative colitis. Its biosimilar versions have the potential to offer the NHS considerable savings, especially when used to treat long-term conditions. Our latest adoption resource looks at how NHS organisations can safely and effectively transition to Inflectra or Remsima. It provides real-life insights from NHS clinicians who have already switched to these new technologies, providing:

  • Practical advice on how to effectively introduce biosimilars into the care pathway, taken from case studies carried out in two NHS Foundation trusts
  • Important advice on possible barriers to implementation and how to overcome these
  • Information on the opportunities for cost-savings and re-investment
  • A process to implement a well-managed safe switching programme to biosimilars.

For more information and to access NICE adoption resource, please visit the NICE website.