A trilogy of biosimilars briefs: 3 key questions in developing successful strategies to counter biosimilars challenges

Biosimilars are on the rise and gathering momentum, full of potential for health systems and patients but fraught with challenges for industry players. As an impending wave of new entrants increases the pressure, how can biologics manufacturers best prepare for the future?

Introducing a trilogy of biosimilar briefs, we consider the importance of addressing three key questions in developing successful strategies. Click one of the buttons below to read how we address each of the biosimilars challenges.

What price has success?
Who’s influencing who?
What’s driving physician behavior?

Biosimilars challenges: A new decade of disruption

Of all recent developments to roil global pharma, few have courted quite such controversy and commotion as biosimilars. Almost but not quite identical to their reference biologic, worlds apart from generics in their structure, complexity and manufacture, and sufficiently unique to demand their own regulatory pathway, they have tested stakeholders across the healthcare spectrum for more than a decade.

Today, the once elite biotech sector commanding blockbuster prices is a crowded and competitive marketplace, upturned by a swell of biosimilars. Since the landmark approval of the growth hormone Omnitrope (somatropin) in Europe in 2006, a further 27 biosimilars of leading biologics have been launched in the region, challenging the original brands at lower cost in various chronic inflammatory diseases, kidney failure, supportive cancer care and diabetes.

And with the recent breakthrough entry of four biosimilar monoclonal antibodies (MAbs) (infliximab, etanercept, rituximab and adalimumab) marking a new level of complexity overcome, the market is gathering pace in its continued evolution, heralding a much tougher environment for biologics originators.

biosimilars - global medicines useAs the dust settles on the first ten years of disruption, the spotlight is now on the future as more MAbs encounter biosimilar competition. Avastin (bevacizumab) and Lucentis (ranibizumab) are among several top-selling biologics facing patent expiration in key countries through 2019, heralding an anticipated influx of biosimilar versions.

Forecasts project that sales of biosimilars will exceed $25bn globally by 2020, with potential to realize cost savings of between $56–$110bn in Europe and the USA alone. As they prepare to compete for market share with originator products currently achieving annual sales of $50bn, a new storm is surely in the making.

Download the full introduction to biosimilars challenges in PDF.

You can also review our webinar about Biosimilars or read its publication on PMLiVE.