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A Unanimous Verdict for Biosimilars


Words by James Coker



Sky-rocketing drug prices has emerged as one of the biggest healthcare issues currently threatening access to treatments worldwide; sadly, however, effective solutions have been in short supply. The debate instead tends to be polarised by noisy condemnations of the pharmaceutical sector by political figures. It is time to put aside the platitude-laden speeches currently dominating the courtroom debate and listen to evidence from emerging practical ideas that can reduce high prices. Biosimilars is one potential solution that deserves its time in the dock for further examination.


Biosimilars offer a realistic solution to high prices because, in theory at least, far less time and money needs to be spent by manufacturers on development costs, with safety and efficacy already vigorously demonstrated by the originator product. “Biosimilars enable early and expanded access to high-quality medicines in resource-constrained healthcare systems,” says Dr Michael Wiechmann, Global Head, Medical Affairs, Biopharmaceuticals and Biosimilars, Sandoz.


Despite the great potential they offer to health systems and patients, the jury of healthcare stakeholders is still undecided on biosimilars. “Despite proven benefits for patients and healthcare systems and increasing confidence among healthcare professionals, access to biosimilars still isn’t equal. Typical challenges to biosimilar uptake include a lack of knowledge or acceptance of biosimilars based on misinformation or misunderstanding about the basics of biologics in general and the biosimilars concept in particular,” notes Wiechmann.


It is time for MA to don its barrister’s wig, flick its collar up, and present the case for biosimilars to the sceptical jury of stakeholders. “MA needs to reach out to a more diverse range of stakeholders, including pharmacists, payers, and patients,” explains Miguel Angel de Blas Martín, Medical Affairs Lead, Biosimilars, Mundipharma. “This is not so much to raise awareness about a specific disease or to differentiate a new product versus standard of care, but rather to increase confidence in the use of biosimilars and to realise the cost savings and release of healthcare resources that can be allocated to further innovation and increased access.”


This last point, that biosimilars offer more than financial savings for health systems, should be seized by MA to encourage patients to join the biosimilar bandwagon. “All healthcare providers should speak with a consistent and clear voice and ensure that a clear message on the benefits of biosimilars is discussed with patients. This seems to be an overlooked aspect that may impact the adoption of biosimilars through a nocebo effect. MA must support and facilitate this dialogue with patients as well,” outlines de Blas Martín.


Biosimilars enable early and expanded access to high-quality medicines in resource-constrained healthcare systems

Working closely with stakeholders, particularly HCPs and regulators, is also crucial, to produce a sensible regulatory regime that enables pharma to produce biosimilars at lower costs and thereby sell at lower prices. “MA should be the credible, scientific partner that helps educate key stakeholders on topics that currently slow down the development process and/or add unnecessary cost into the system, such as required Phase III trials for all biosimilars and the lack of a global comparator. By removing these hurdles while maintaining the rigorous standards of biosimilarity, manufacturers can focus on the most critical development and regulatory pathways, leading to higher cost efficiency,” says Wiechmann.


MA needs to invest in a range of new hats in addition to their barrister’s wig if biosimilars are to make a noticeable dent into rising drug prices. Their discussions with stakeholders should go beyond medical, demonstrating strong business acumen and the ability to persuade relevant parties to think broadly about the benefits biosimilars can bring to the wider healthcare ecosystem. The wind is set to be fair for MA to put on its skipper hat and sail off with a diverse range of passengers in the same direction: where the sun is rising on a new dawn of affordable, high-quality medicines.