Worldwide experience with biosimilar development

Abstract

Limited access for high-quality biologics due to cost of treatment constitutes an unmet medical need in the US and other regions of the world. The term “biosimilar” is used to designate a follow-on biologic that meets extremely high standards for comparability or similarity to the originator biologic drug that is approved for use in the same indications. Use of biosimilar products has already decreased the cost of treatment in many regions of the world and now a regulatory pathway for approval of these products has been established in the US. The Food and Drug Administration (FDA) led the world with the regulatory concept of comparability and the European Medicines Agency (EMA) was the first to apply this to biosimilars. Patents on the more complex biologics, especially monoclonal antibodies, are now beginning to expire and biosimilar versions of these important medicines are in development. The new Biologics Price Competition and Innovation Act (BPCIA) allows the FDA to approve biosimilars and allows the FDA to lead on the formal designation of interchangeability of biosimilars with their reference products. The FDA's approval of biosimilars is critical to facilitating patient access to high-quality biologic medicines and will allow society to afford the truly innovative molecules currently in the global biopharmaceutical industry's pipeline.

Biosimilar vs biological agents in rheumatology: When are biosimilar agents similar enough?

“…It has been anticipated that by 2016, ten of the top-selling 20 drugs will be biologics and of these, three (Adalimumab, Rituximab, Infliximab) are monoclonal antibodies or (etanercept) a fusion protein containing antibody components currently widely used to treat rheumatic disease [19]. The Rheumatology field has adopted routine use of biologics including monoclonal antibodies, and it is therefore a desirable market for BS research.…”

A European perspective on the market accessibility of biosimilars

“…41 In contrast, the US Food and Drug Administration can allow substitution of a biosimilar for a reference biopharmaceutical medicine without approval of the prescribing physician, but only on the condition that interchangeability has been proven. 24 Even if a European country were to allow substitution of a biosimilar for a reference biopharmaceutical medicine, it remains to be seen whether physicians who have gained long-term experience with prescribing reference biopharmaceutical medicines would be willing to switch existing patients to a biosimilar medicine. 25 In this respect, it should be noted that biosimilar medicines have gained a foothold in some European countries as the result of a strategy to persuade physicians to start new patients on a biosimilar rather than to switch existing patients.…”

“…23 This cost picture not only increases prices of biosimilar medicines, but also is expected to limit the number of biosimilar companies that enter the market and thus reduce price competition in the off-patent biopharmaceutical market. 24 The price difference between reference biopharmaceuticals and biosimilar medicines may also depend on their respective market shares: more substantial price differences have been documented in countries where biosimilars attained a higher market share. For instance, in Germany, biosimilar erythropoietins had a market share by volume of approximately 14%-30% after 2 years on the market, and were priced at around 75% of the price of the reference biopharmaceutical medicine.…”

Glycoengineered Yeast as an Alternative Monoclonal Antibody Discovery and Production Platform

“…Global biologic drug sales reached $93 billion in 2009 and the sales are expected to grow at least twice as fast as those of small molecules (McCamish and Woollett, 2011). The rapid market growth and the promise of successful rate of developing biologic drugs has drawn the attention of traditional small molecule pharma into the biotechnology business.…”