Challenges & Opportunities In The U.K. Biosimilar Market

By Warwick Smith, director general, British Generic Manufacturers Association

Despite having a generics market which fulfils nearly three-quarters of all prescriptions in the U.K., delivering some of the lowest medicines prices in Europe as a result, there still remains a surprising degree of mystery surrounding biological and biosimilar treatments.

For medicines which have enormous proven as well as future potential benefits for patients and payors, the U.K. is still to an extent going through an education process aimed at establishing the advantages of biosimilars and making the case for clinicians to adopt their use.

Currently, there are four biosimilar medicines available in the U.K. However, this is set to increase due to a number of factors including patent expiries, increasing clinical awareness and knowledge, as well as supportive clinical guidance from organizations such as the National Institute for Health and Care Excellence (NICE).

The supportive environment from NICE has been particularly crucial. In November last year, NICE published its review of Erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating anaemia in cancer patients being treated with chemotherapy. The appraisal covered two biosimilar medicines, Binocrit and Retacrit, each of which is referenced to as Eprex.

The review concluded that erythropoiesis-stimulating agents (ESAs; epoetin alfa, beta, theta, and zeta and darbepoetin alfa) are recommended, within their marketing authorizations, as options for treating anaemia in cancer patients receiving chemotherapy. Furthermore, if different erythropoiesis-stimulating agents are equally suitable, the product with the lowest acquisition cost for the course of treatment should be used.

In February of this year, NICE published its review of infliximab, adalimumab, and golimumab for treating moderately to severely active ulcerative colitis. The guidance incorporated biosimilar versions of infliximab and stated that if more than one suitable treatment is available, the least expensive should be used by clinicians. 

Most recently, NICE published its Final Appraisal Determination which recommended biosimilar infliximab as an option for the treatment of severe rheumatoid arthritis following a Multiple Technology Appraisal. NICE also recommended that treatment should be started with the least expensive medicine, which is likely to be the biosimilar.

While these announcements are positive, a number of other changes need to happen if biosimilars are to reach their full potential in the U.K.

A recent study undertaken by GfK Market Access on behalf of the European Biosimilars Group (EBG), a sector group of the European Generic Medicines and Biosimilars Association, outlined a series of measures that will drive the establishment of a sustainable biosimilar medicines market.

GfK’s report highlights that there are four elements which need to be considered holistically to provide a sustainable policy framework for the biosimilar market. These are:

• Education and understanding
• Experience and use
• Rational decision making
• Sustainable pricing

However, more specifically, for the U.K. to maximise the benefits to patients and the NHS, it is important that the following measures are promoted appropriately:

• Where the clinical considerations are equivalent, clinicians should routinely prescribe biosimilar medicines for new patients rather than the equivalent more expensive originator product.
• Clinicians should consider changing patients to a more cost-effective equivalent biosimilar medicine when one becomes available given clinical and scientific evidence and appropriate clinical protocols, including consultation with the patient and pharmacovigilance.
• There are no unnecessary barriers to the use of biosimilar medicines within the NHS, nor to their development and production in the U.K.

As acknowledged by the NHS England Chief Executive, Simon Stevens, in his Five Year Forward plan, the NHS is at a “crossroads” and needs to change and improve as it moves forward. Long-term conditions now account for 70 percent of the health service budget coupled with a £30bn funding gap. Biosimilar medicines offer considerable savings to the NHS through significant price reductions from a high cost base of the originator product.

As biosimilar medicines are often used to treat long term conditions such as diabetes and multiple sclerosis, ensuring they are appropriately used across the NHS would clearly contribute to reducing the funding gap outlined in the Five Year Forward, while also improving access to life saving medicines. The use of biosimilars also increases access to important medicines by creating competition and encouraging further innovation in life-saving therapies. Competition provides the necessary incentive for originator companies to develop new biological medicines, and biosimilars themselves often demonstrate incremental innovation delivering additional clinical benefit or added value, enhancing patient treatment and outcomes.

The cost savings due to competition from biosimilar medicines and the resultant reduction in cost per QALY (quality-adjusted life year) means that biosimilar medicines may also be approved by Health Technology Appraisal agencies when the equivalent originator product was found not to be cost-effective.

The use of biosimilar medicines, therefore, does not just save the NHS money, which can be used to fund other treatments and the development of other medicines, but it makes specific medicines available to patients within the NHS which might otherwise not be approved for use.

However, the changes required to drive the biosimilar market need policy-making to keep pace and recognize the changing dynamics. One positive addition is the recent publication by NHS England of a ‘What Is a Biosimilar’ document. Created in collaboration with industry and other partners including NICE, it aims at providing clinicians with the information they need, which will drive uptake and adoption. However, this in isolation isn’t enough.

New and more nuanced thinking is also required when it comes to regulation among other issues and without it, the U.K. could face falling behind the rest of Europe and elsewhere in the world in gaining access to these vital medicines.