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What makes the difference in the biosimilar battle?

The biosimilar market is set to get competitive but only players with a clear differentiation will succeed


As biologic medicines play a more significant role in patient care across a number of disease areas, the emergence of biosimilar medicines across Europe and in the United States brings the promise of new sources of therapeutic value.

The prospect of more cost-effective treatment options that are safe and effective opens up opportunities for healthcare systems to expand access to biologics for more patients, free up resources for investment in new areas, and bring relief to pressured drug budgets. As more and more pharmaceutical companies recognise this opportunity, the competition in the field of biosimilars is certainly getting more serious. Taking the example of multiple blockbuster monoclonal antibodies close to their patent expiry dates, we can see that numerous big pharma companies like Merck, Amgen and Pfizer and even smaller to medium-sized generic or specialty players like Cinfa, Mylan and Gedeon Richter hope to get a slice of this pie at the end of the day.

The regulations regarding biosimilars of bodies like the FDA and the EMA are changing and evolving. The FDA is showing more openness, as it wants to see more approved biosimilars in the near future, while the EMA is showing more scepticism in this respect. Eventually the attitudes of the two authorities will reach the same point. The question is if the ‘salt and pepper approach’ will be applied? The salt and pepper approach means that during the approval process, phase III clinical trials do not need to be considered. Quality and characterisation procedures would make the salt and pepper approach viable, as developers have very precise in-house methodologies. How it would affect the behaviour and attitude of prescribers, however, would be the next question. An increased level of resistance could be encountered in the beginning, but as in generic business strategies, this hurdle can be resolved later by obtaining sufficient levels of real-world clinical evidence.

The market access requirements are indisputable and are getting clearer as time goes by. Market access is still a hurdle for biotech companies, but the rapidly changing environment provides positive future promise in this area. Some national agencies treat biosimilars as special generic medicines with a lower percentage of obligatory price decreases. If we are aware of the country-specific market access requirements of commercialising biosimilar drugs, then it is almost a logical step for the company, if not, then it could be a real entry barrier.

Marketing is the least transparent part of the value chain of commercialising biosimilars. What we have already learned from the past is that the biosimilar uptake is therapy- (chronic versus acute treatments), country- (biosimilar friendly environment supported by quotas versus those with no incentives) and price-specific (discounts on the original product).

The biosimilar market looks set to get very competitive soon. For the various players a clear differentiation will be the fundamental success factor.

In the past years pharmaceutical companies have undertaken the development of value-added services to support their customers with varying success. We could see a lot of marketing activity where the marketing professionals express their creativity but where the outcome for healthcare professionals (HCPs) and patients is not very effective. It is essential for marketing professionals to understand what the needs of HCPs are, as well as those of their patients.  Solutions need to be developed based on that understanding and validated in feedback loops with the stakeholders.

If the therapeutic attributes and the prices are comparable, the expectation would be that the customers and stakeholders will value the services offered and will use them as a decision factor to prefer one biosimilar to another.

In conclusion the challenges for companies developing biosimilars are substantial and require a high level of expertise in various fields. During the long development of a biosimilar, the company has to observe the developing regulatory environment and if required adapt to the changing guidelines. Currently market access is also a considerable hurdle for biosimilars, and a close monitoring of the changing requirements from HTA authorities is required in order to ensure rapid market uptake.

Finally the sustainability of the biosimilar market will also depend on the mutual understanding between companies and their key stakeholders, such as regulatory agencies, HTA bodies and HCPs regarding their needs and expectations. Ultimately the goals are the same: to provide high quality biosimilars to an increasing number of patients and thereby contribute to an improved healthcare outcome.

Article by
David Ashur

is global biotech marketing manager at Gedeon Richter

3rd July 2017


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