Biopharmaceuticals (includes Biologics)
This presentation will examine the key strategies being adopted by the innovator companies and discuss the impact these strategies are likely to have on the regulatory strategy and the future market for biosimilars.
Over the last 25 years, biologic medicines have transformed how several chronic and life-threatening diseases are treated. Because of the great value of these innovative biologic medicines and the capital required to bring them to market, they are able to command high prices. As such, biologic medicines garner most of the 10 top-selling pharmaceutical product slots in the largest markets. The pending expiry of patents for many of these most successful biologic medicines presents an opportunity for developing biosimilars with potential to gain a share of the lucrative biologics market. Regulatory pathways for biosimilars are in place in most major markets around the globe, starting with the European Union (EU) more than a decade ago. Starting in 2005, the EU has approved more than 40 biosimilar products. Seventeen biosimilars have already been approved by the US Food and Drug Administration (FDA), but only seven biosimilars have been launched.
While there is robust activity on the biosimilars development front, there are equally interesting and multipronged developments from biologic innovator companies to safeguard the market value of their products. Examples include development and registration of ‘biobetter’ versions of the originator biologics, offering improvements over the original; dropping the price of the originator biologic; manufacturing and marketing regional branded versions of their own biologics in partnership with other companies, tying one biologic product to another’s approved use and making a new biologic product – utilizing rare disease protections and exclusivities – to protect the originator’s indication.