Biosimilars - Transforming Global Patient Access to Treatments

Biosimilars provide cost-effective alternatives to biological drugs and represent a growing opportunity, however Europe lacks a harmonized regulatory approach.

Gabriela Marton
Regulatory Affairs Director and Quality Director at Arriello

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The current situation

Biological medicines represent a major advance in the treatment of serious pathological conditions, such as cancer, neurodegenerative, and autoimmune diseases. Biosimilars, as their cost-effective alternatives, improve patient access to modern therapy. As these therapeutics become trusted and more widely used by clinicians, we can expect a larger number of new biosimilars coming onto the market as the patents and market exclusivity linked to innovator products expire. By 2019, more than 14 innovative biological products lost their orphan designation market exclusivity, and by 2029 another 34 innovative biological products will join them. With regard to patents, by 2023 those will expire for most formulations, creating a very fruitful period to develop important biosimilars.

While biological drugs are the originators of new treatments, such products are costly to develop and procure. A newly developed molecule can be 10-15 years in the development phase and incur over 1 billion euros or dollars in R&D cost. Once that formula’s patent and market exclusivity expires, competing manufacturers can bring a biosimilar to market at a fraction of the price, enabling cheaper procurement options for governments and potentially giving patients much wider and more affordable access to treatments. These products might take 30-50% less time to develop, and cost up to 70% less than their biologic originals – savings which can be passed on to healthcare providers and patients. To date, biosimilars are thought to have saved the EU up to $44 billion in healthcare costs (1).

Biosimilar treatments offer comparable benefits for the healthcare system as generic drugs, though they cannot be compared. Generics are small-molecule formulations identical to the innovative product, while a biosimilar can only aim to be highly similar to the innovative product. However, both generic and biosimilar products will be expected to have the same clinical effect as the respective innovative product.


Speeding Development

As biologics are very important in treatment of oncological, rheumatological, endocrinological, and other rare diseases, increasing numbers of manufacturers are moving from small-molecule developments to the more complex process of developing larger molecules.

Although not biologically identical, biosimilars are ‘highly similar’ to the original/reference product/innovator (think identical twins, but each with their own unique fingerprints). This means that when companies are going through regulatory assessments they can reuse information developed by the original innovator company. It’s because of this that the development of the biosimilar can be several years faster: an enhanced comparative quality study is recommended, rather than extensive clinical and non-clinical studies, to support product registration.


Growing Understanding

Interest in biosimilars is strong, and amplifying as understanding grows around this alternative route to medicines access – and as trust builds. Initially, the fact that biosimilars are not exact equivalents of reference drugs, may not come in the same pharmaceutical dosage as the originator, and testing can reveal insignificant clinical differences, caused some concerns about the safety of any interchangeability in the treatment between biosimilar and originator and vice versa, or between two biosimilars. Yet, as multiple studies have been performed to demonstrate the low risks of interchangeability, and as authorities’ interest in supporting such studies has increased to be able to indicate where impeachability is recommended, those inhibitors have decreased in intensity.

Agreement among the various authorities about how to handle biosimilars will help further here. Today, more than 70 biosimilars are registered in the EU and others are under evaluation, thanks to efforts by the EMA to continuously improve guidelines and provide appropriate support to bring these products to market. Similar efforts have been seen across each national drug authority around Europe and the heads of medicines agencies (Coordination Group for Mutual Recognition and Decentralised Procedures) to provide access to biosimilars.


Navigating European Policy

There is a way to go, however. Currently there isn’t a harmonised approach in Europe concerning interchangeability. Rather, each member state’s national medicine authority can decide this on a case-by-case basis.

More encouragingly, most European countries have now succeeded in achieving widespread acceptance of biosimilars by all parties: payers, providers, and patients. It is important that all parties understand the benefits of having such medicines available on the market.

Companies may need some help navigating the differences, as the balance achieved by good policies can be easily destabilised by measures ranging from exclusive tenders (which can negatively impact biosimilar sustainability and lead to supply shortages), to fixed reimbursements pricing (which can destabilise competitive markets and discourage manufacturers’ participation). There are also many countries that do not yet have a policy for incentives, or have not yet fully implemented the policies they have been developing. The hope is that respective national and regional regulators will increasingly share best practice rather than reinvent the wheel for their own market.


Building Trust

Other challenges are linked to education. Education around biosimilars is badly needed, not only for healthcare professionals but also for patients, decisionmakers, and perhaps also the media – not just about the differences and relative benefits between biologics and biosimilars, but also how such products come into use, and how they are administered or self-administered, as medicine develops together with technology.

This education is vital to build trust, and to support interchangeability in treatment, where applicable. Without this confidence in substituting original treatments with new biosimilars, healthcare professionals will continue to recommend the reference product, which will stifle competition and lead to price increases over time, a phenomenon seen also in generics over time.

Biosimilars present an exciting opportunity to bring important treatments to market more affordably and in higher volume, putting the needs of patients first. Life science companies that fail to get a head start will be left behind in the race to bring biosimilars to market.


Reference 1. Visit:

This article is taken from European Biopharmaceutical Review January 2021, pages 68-69. © Samedan Ltd


Gabriela Marton is Regulatory Affairs Director and Quality Director at Arriello, where she leads the regulatory affairs functions, developing robust and efficient market access and post-marketing strategies to support pharmaceutical companies’ business needs.

Gabriela has over 14 years’ experience in regulatory affairs and compliance within the pharmaceutical and food supplements sectors. Previously, she was an independent regulatory consultant, and has held several positions in regulatory affairs and compliance in various pharma companies, one of which was GlaxoSmithKline, where Gabriela started her regulatory career and worked for almost a decade.

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