Lessons from the “Biosimilarized”

There is still much uncertainty as to the ability of biosimilars to compete effectively with biologics.

A new report, published in the July 13 issue of PharmacoEconomics, explores this issue by examining foreign markets. The findings confirm that discounts for biosimilars do not determine global uptake and prescription incentives to encourage the use of biosimilars are hit and miss.

This begs the question, will there be an economic model for biosimilars in the U.S. like that of generics? The authors say there is no such model in France, Germany, Italy, Spain, the United Kingdom and Japan. But they identified a new phenomenon:  biosimilars in foreign markets have been have been able to take market shares from biologics. And, a class of biosimilars called erythropoietins (EPOs which are used for long-term treatments), appear to be following a “monopolistic competition model.”

The uncertainties

There is still much uncertainty as to the ability of biosimilars to be competitive in the highly innovative biologic sector and as to the main drivers of their access to the market. Some price competition is expected with biosimilars. But, unlike generics, biosimilars and originators are scientifically and technically different which might affect the competition.

“Laboratories producing biosimilars will face a range of competitive strategies implemented by firms commercializing originators, particularly with the development of second- or third-generation products that could be therapeutically superior to first-generation products. These subsequent-generation products actually tend to make the first-generation products and their copies, the biosimilars, obsolete,” the authors wrote.

But what seems to be at the forefront of concerns for physicians is whether biosimilars should be substituted for originators.

The report analyzed the two main therapeutic classes that have been “biosimilarized.” This included granulocyte colony-stimulating factors (GCSFs which are used for short-term treatments) and EPOs. Data between 2007 and 2014 was collected.

Researchers found that biosimilar GCSF uptakes are high in countries with dominant hospital markets, such as Spain where the highest total biosimilar GCSF uptake was recorded in 2014 at 56.8 %. The lowest was reported in France (11.8 %), which is a GCSF retail market.

For EPOs in 2014, the biosimilar uptake was 32.9 % in Germany and 8.3 % in France, which both have retail markets. In Japan (a hospital market), it was 10.6% and in Italy and in Spain (both hospital markets), the biosimilar EPO uptakes were 21.7% and 23.0 %, respectively. In the United Kingdom, which is a hospital market, the biosimilar EPO uptake was only 2.4 %.

“Beyond these national discrepancies, an overall trend is striking for GCSFs:  the more the markets have hospital-dominant distribution channels, the more the markets are small and the biosimilar GCSF uptakes are high. No such relation exists between EPO distribution mixes, EPO market sizes and biosimilar EPO uptakes,” the authors wrote.

The Takeaways

When developing national, regional or sub-regional policies promoting biosimilar prescriptions (such as incentives or quotas), or in considering substituting biosimilars for originators, the authors recommend focusing on the scientific differences between biosmilars and originator products, between first versus second generation ratios, prescription habits for hospitalized patients and outpatients.

“In the future, the arrival of other biosimilars should be the reason for health policy stakeholders to consider the possibility of switching first-generation biologics - biosimilars or not - for some subsequent generation of biologics within the same therapeutic class for economic reasons,” the authors wrote.

“As a first step, it is up to hospitals, decentralized purchasing structures and regional health authorities to encourage the use of biosimilars by defining locally:  (1) the scientific and economic conditions for their inclusion in tenders, and (2) their own interchangeability policies between a biosimilar, its originator or even subsequent biologics belonging to the same class.”

-      "Competition Between Biosimilars and Patented Biologics: Learning from European and Japanese Experience,"

PharmacoEconomics. July 13, 2016. DOI: 10.1007/s40273-016-0428-6

References:

Francois Bocquet, Anais Loubiere, et al. "Competition Between Biosimilars and Patented Biologics: Learning from European and Japanese Experience,"  PharmacoEconomics. July 13, 2016. DOI: 10.1007/s40273-016-0428-6