The first biosimilar (Omnitrope = somatropin) was registered by the EMA (European Medicines Agency) in 2006. By contrast,  the FDA was not able to register any US biosimilars until 2015 when Zarxio (filgrastim-sndz) became the first biosimilar product to receive US approval.

Since then, the FDA has been playing “catch-up” so that by mid-2024, the number of US-approved biosimilars was 60 compared to 106 biosimilars that have been approved in Europe.

One very important factor in particular contributed to the 9-year gap between the first European biosimilar and the first to gain FDA approval. This was the US delay in creating and implementing the relevant legislation necessary for creating a suitable regulatory framework.

It is therefore easy to understand why the two markets have developed in different ways and at different speeds. Different regulations, different policies on substitution, different attitudes to switching and different healthcare environments are all factors that have contributed to the two markets diverging quite significantly from one another.

Another difference that has impacted the two markets has been the differing aptitudes to inclusion (or not) of biosimilars in healthcare supply tenders. This in turn prompts the question about who should make decisions about whether it is permissible or, indeed, appropriate to change the biological treatment that a patient is receiving. Should it be the physician who is treating? The pharmacist who is dispensing? Or the insurer who is paying?

These are just some of the factors that impact and interact with the biosimilar markets and make for a complicated environment. With generics, the issues are much simpler. Switching a patient from a brand to the generic equivalent is not a contentious issue; nor is switching between different manufacturers’ generics. or substituting a different generic in place of the one that the patient was previously using. These are usually straightforward processes and far simpler than changing biological treatments. Changing biological treatments is understandably far less straightforward.

The webinar sets out to try to clarify a potentially rather confusing picture and to show the impact of the different factors that have affected and continue to affect the different markets in their different regulatory and legislative environments.

Areas Covered

• Regulatory environments - a comparison
• Legislative history
• What drives the different biosimilar markets
• Major players
• How biosimilars  differ from generics
  

Who Should Attend    

• Strategic planners
• Marketing Directors
• Product Managers
  

Why Should You Attend

Biosimilars potentially offer a very tempting target and. like many tempting targets, they also bring with them potential dangers.

What is the tempting part? The extremely high prices of the brands in place of which the biosimilars might be used. For example, Humira has a US list price of $7,299. This makes it a very tempting target to copy, even if competition or state intervention forces price cuts.

By contrast, the price for the same pack in France is €503 (=US560). This leads on to the very important question - is it possible that US government price control measures could lead to similar prices in the US? If so, this would certainly affect the attractiveness of the market.

The Inflation Reduction Act (IRA) became law in the US on 16 August 2022. Apart from its other measures, a particular aim is to reduce the burden of Medicare by cutting more than $100B per year from its expenditures, and biological product costs incurred by Medicare are amongst its targets.

In Europe, many countries now include biosimilars in tenders on the basis that they are, in effect, interchangeable. In such an environment, price cuts by the manufacturers become a part of their attempts to win the tenders.

Is it possible to still make money in such an environment? Could the same phenomenon occur in the US as more and more companies enter the market?

The webinar sets out to look at the US and European markets for biosimilars, compare and contrast them, and highlight some of the factors that potential market entrants need to consider.

Topic Background    

Biosimilars can be viewed as the new generics. There, of course, are significant differences between the two fields, but also many similarities.

The aim of this webinar is to look at both contrasting aspects of this field so as   to highlight the areas where they overlap and those where they differ from each other. In addition, the webinar takes a look at how European and US biosimilar markets have developed differently. It examines the potential attraction of biosimilars as well as the difficulties that potentially lie in the path of companies considering an entry into this market.