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Out-Law Analysis 4 min. read

Overcoming challenges in the biosimilars market

Manufacturers that can successfully navigate a complex patent environment, satisfy regulatory requirements, and overcome challenges to penetrate the market will benefit most from the expected substantial growth of Europe's biosimilars market.

A potted history of biosimilars in Europe

Biosimilars are medicines that seek to compete with originator biologic products. Biologics contain active substances derived from biological sources and are often large, complex molecules such as antibodies.

Biosimilars are typically around 30% less expensive than originator products and, in the EU, offer considerable cost savings. As more originator products come off patent - i.e. their product patent expires - biosimilar manufacturers will be seeking innovative ways to clear the path of secondary patents and achieve good market penetration.

In 2019, five biosimilar products were approved in the EU, so there are now 58 biosimilars with an EU marketing authorisation. Biologics are predicted to comprise more than 25% of the pharmaceutical market by 2020. The role of biosimilars in the growth of this market will be important.

Antibodies and fusion proteins have led the way in biosimilars hitting the market in Europe. The first of these, infliximab, which treats diseases such as rheumatoid arthritis and Crohn's, came off patent in 2015 and prompted a number of biosimilars to enter the market. It took a couple of years for those biosimilars to penetrate the UK market, but they have now have achieved significant traction with IQVIA figures in October 2018 suggesting UK market penetration of over 90%, and more than 50% in each of Germany, France, Italy and Spain.

Roberts Tracey

Tracey Roberts


Secondary patents can present one of the main hurdles biosimilar manufacturers must overcome when seeking to get their alternatives to market. Bespoke strategies are necessary to navigate these patent thickets successfully

Following infliximab, etanercept, rituximab, adalimumab and trastuzumab have all come off patent and biosimilars of each have entered the European market. They treat a range of autoimmune diseases and types of cancers.

Their market penetration across Europe has varied. For instance, as of October 2018, the UK market for etanercept, which came off patent in 2016, showed biosimilar uptake of more than 80% but in Germany had closer to 50%. Trastuzumab went off patent in Europe in 2018, and by October 2018, the biosimilar had more than 60% penetration in the UK, and nearly 100% in Denmark and the Netherlands.

Adalimumab is the world's best-selling prescription drug and, when its product patent expired in 2018, biosimilars entered the market and made a huge impact. By November 2018, Reuters reported that AbbVie, the originator company, was offering discounts of up to 80% in parts of Europe to account for the increased competition.

Bevacizumab is the next major biologic set to go off patent in Europe in 2020. Already, biosimilar manufacturers have been manoeuvring via court actions to prepare for launch.

These initial entrants have set much of the landscape for what is to come, with biosimilar entrants looking to clear secondary patent thickets and engage healthcare providers, regulators, clinicians and patients to ensure market penetration, but more can be done.

Freedom to operate

Once the product patent expires, originator biologics often have additional patent protection covering things such as the dosing regime, formulation and second medical uses. From an originator's perspective, it is unsurprising that they would look to secondary patents to help preserve their market monopoly and leverage a return on their R&D investment. However, secondary patents can present one of the main hurdles biosimilar manufacturers must overcome when seeking to get their alternatives to market. Bespoke strategies are necessary to navigate these patent thickets successfully and avoid being issued with injunctions which can delay launch and have an impact on reputation and the bottom line.

We have seen some biosimilar manufacturers seek, with varying success, so-called 'Arrow declarations' in the UK courts, which state that a product was part of the common general knowledge or obvious at a particular point in time. This is deployed in particular where there is a thicket of secondary patent applications pending at the European Patent Office. An Arrow declaration provides manufacturers with a level of commercial certainty that they can launch without fear of being subsequently pursued for patent infringement in the event secondary patents are granted. UK court-granted Arrow declarations might also serve as an infringement defence in other European countries, although this is untested.

An innovative strategy to overcome complex patent landscapes and regulatory hurdles will make the difference for future biosimilars obtaining first access to market and return on investments.

Costs, pricing and savings

Biologics are among the most expensive drugs to develop, owing to the complex production process. This is true for biosimilars too, and the regulatory process that applies to biosimilars mean that they typically take longer to get to market at greater cost than traditional generic products.

While price reductions upon entry to market of biosimilars tend to be less dramatic than in the case of traditional generics, it does still offer scope for savings, which has been widely recognised by European policymakers and health authorities.

NHS England envisages savings as a whole from biosimilars of between £400 million and £500m per year by 2021 if it can increase uptake of "best value biologic medicines". In support of this, NHS England has set a target of 80% penetration within the first year of a biosimilar first becoming available.

Some countries have gone further to encourage the use of biosimilars in place of originator biologics. Germany last year introduced new legislation to encourage greater pharmacy-level substitution for biological drugs, while in Denmark biosimilars approved by the European Medicines Agency (EMA) based on reference originator biologics are automatically considered to be interchangeable and there is a mandate to switch to the lowest cost medicine.

The approach varies from country to country across Europe, however, as the EMA does not regulate therapeutic interchangeability, switching, or substitution of a reference product by a biosimilar medicine, leaving it to individual EU member states, health authorities and payers. Biosimilar manufacturers may therefore seek to work with individual health authorities, policy makers and payers to introduce more favourable regimes for biosimilars in member states.

Achieving market penetration

In the absence of a mandate to switch away from higher-priced originator biologics to biosimilars, decisions on what medicines to prescribe are often left to individual doctors.

Doctors often use clinical or prescription guidelines to inform them of the latest products available for treating certain conditions. There is therefore an onus on biosimilar manufacturers to make the positive case for their products to be referenced in the guidelines set by bodies such as the National Institute for Health and Care Excellence (NICE) in England, and to educate clinicians.


There is a huge potential market for biosimilars and it will be those manufacturers that take proactive steps on multiple fronts to challenge patents, watch competitors and ultimately ensure market penetration via lobbying for guideline changes, pricing and education, that ensure success for their products and savings for healthcare systems.

Tracey Roberts is a life sciences expert at Pinsent Masons, the law firm behind Out-Law. Roberts discussed the issues around biosimilars market access at the C5 pharma and biotech patent litigation conference in Amsterdam, held over 25-26 February 2020.

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