IQVIA Analyst Looks at Current Developments and the Decade Ahead for Biosimilars

The global biosimilars market is beginning to take on a more defined shape as blockbuster therapies lose their exclusivities, the United States sees the entrance of the first anticancer biosimilars, and Europe gains experience and savings with adalimumab biosimilars. But what will the coming decade hold in terms of new development projects and global sustainability?

During the first day of the SMi 10th Annual Biosimilars Conference, being held in London, United Kingdom, Aurelio Arias, senior consultant, thought leadership, IQVIA, gave a look at the biosimilars landscape to date and offered insights into what may lie ahead in the coming decade.

Arias began with an overview of what commercial lessons have been garnered from experience with biosimilars so far; As of May 2019, IQVIA data demonstrate that biosimilar penetration has been the greatest in hospital settings, where healthcare systems may direct the choice of which agent can be given to patients. In the EU5 nations (the United Kingdom, Germany, France, Italy, and Spain), biosimilar infliximab has reached penetration levels of as high as 93%, biosimilar etanercept has risen to 83%, and biosimilar rituximab has reached 91% (all in the United Kingdom), while biosimilar trastuzumab has achieved 85% penetration (in France).

However, products that are traditionally dispensed in a retail setting have had far lower uptake; Biosimilar insulin glargine has reached a high of 23% penetration, and biosimilar insulin lispro has reached just 8% penetration, both in Italy. Adalimumab, which may be dispensed in a retail or hospital setting, has reached a high of 57% uptake in the EU5, once again in the UK setting.

These findings show, said Arias, that “when you take the decision to prescribe away from the individual physician,” higher uptake is observable.

It is important to note, said Arias, that uptake in individual EU nations varies widely by region. In Germany, for example, some regions have achieved more than 70% uptake of biosimilar infliximab and adalimumab, while others have uptake levels under 60%. Indications, too, show wide variation. German prescribing of biosimilar infliximab is 56% in rheumatoid arthritis versus 75% in Crohn disease, for example, representing what Arias called a “gradient of decisions to prescribe” within individual markets.

Europe also has a great variety of biosimilar discounts, ranging from just 10% to as much as 80% in some markets. Among anti—tumor necrosis factor biosimilars, net price discounts, as opposed to list price discounts, have ranged from 10% to 55% in France, from 30% to 70% in Germany, from 40% to 50% in Italy, and from 30% to 80% in the United Kingdom. “I would say that in general, adalimumab lies in the higher discount range, [about] 80% and 70%,” said Arias, adding that “this is where the battle is won: at the net price level.”

Looking to the future, Arias sees reference biologics “on the cusp of being shaken up.” IQVIA’s data show that the top 10 biologics by global sales, as of the second quarter of 2019, include those already competing with biosimilars or facing upcoming losses of exclusivity: adalimumab, insulin glargine, etanercept, infliximab, insulin aspart, bevacizumab, and trastuzumab.

The top 10 also includes 3 drugs that, while they face later losses of patent protection and exclusivity, currently comprise $25.3 billion of global sales: pembrolizumab, nivolumab, and ustekinumab. These drugs, said Arias, will represent large opportunities for biosimilars when they come off patent.

Those opportunities that hold hope for more than $1 billion in sales will be grasped primarily by the larger players in the biosimilars space, said Arias, and the market will likely see fierce competition and high price erosion for these drugs.

By contrast, products that can be expected to sell in the $100 million to $1 billion range will likely be targeted only by small and midsized biosimilar players and will see less competition and lower levels of price erosion. Arias foresees drug makers from China and India, who can operate at a lower cost base, playing a key role for these therapies. Among drugs that can expect to sell less than $100 million, such as some orphan drugs, Arias sees low levels of viability for these projects.

Notably, Arias said that, in order for biosimilars to deliver on their promise in the coming years, the US market must begin to open up to biosimilars. Non-EU and non-US markets, as of the second quarter of 2019, comprised approximately $800 million in biosimilar sales, compared with the approximately $10 billion global market. On their own, these markets, which already have low coverage of biologics and therefore low sales of these agents, are not large enough to justify biosimilar development programs. Therefore, if global biosimilar development projects are to be sustainable, the United States will need to succeed in its own biosimilar ambitions.