Era of the Biosimilar: The Inevitable Change

Biosimilars. They bring cheap prices to patients and healthcare payers, but for biopharmaceutical companies, such products impact the sales of innovative biopharmaceuticals. The pros and cons of biosimilars have been under discussion for some time in the bio/pharma industry, but the debate is now gaining increased momentum as the US moves closer to solid guidance concerning the development of biosimilars.

In Europe, the EMA has had approval procedures in place for biosimilars for years and many products are already available in the EU marketplace. In the US, however, the subject is a little newer and there are still many concerns.

Last week, BioWorld published a new report on biosimilars. “The emergence of this new drug development sub-industry translates into opportunities for patient access to very expensive but effective biotech-based therapeutics,” BioWorld’s executive editor, Lynn Yoffee, said in a statement. “But the development of biosimilars brings myriad questions related to drug efficacy - since they are not exactly duplicates, just similar - as well as quality, safety and interchangeability with originator products.”

Indeed, the above concerns of safety and efficacy have long been iterated by innovator biopharmaceutical companies

In February 2012, FDA invited comments on three draft guidance documents concerning biosimilar product development in the US. In response, biopharmaceutical company Amgen explained that clinical studies “will be necessary to demonstrate biosimilarity for the forseeable future.”  The company also firmly pointed out that biosimilars are not generic drugs and that the scientific understanding of the reference product is often incomplete, although the analytics of protein biologics are improving.

Many other companies had similar concerns to Amgen, but the era of biosimilars is inevitable in the US. Fortunately, many companies are beginning to accept this. On Friday, Amgen released a statement expressing its support for biosimilars initiatives that focus on sound science and patient safety. Once again, however, Amgen emphasised that biosimilars are not identical to their reference product.

“Biologics are so complex that they can usually only be made by a living cell.  In fact, when made by different manufacturers, they differ from each other.  They are also very large compared to chemical drugs and can be more sensitive to storage and handling. As a result biologic medicines have the potential to cause an unwanted immune response, which can show up months after taking the medicine,” said the Amgen statement.

BioWorld believes that biosimilars will have a bright future ahead of them, but the products still have to prove themselves. In the BioWorld release, biosimilars expert and Washington editor, Mari Serebrov, said, ”As the US continues to wait for its first biosimilar to step up to the plate, global players are already betting on follow-on biologics to be one of the biggest hits in town. To earn that status though, biosimilars will have to show payers the money pretty quickly by delivering the power of biologics at a price economically strapped countries can afford.”

And, as Amgen emphases, by delivering therapies that are as safe and effective as their reference products. Amgen has made several suggestions to make sure that the biosimilars era delivers safe therapies. Amgen suggests that patient medical records must accurately reflect the biologic medicine that is being taken, and that physicians be informed when an interchangeable biologic substitution has occurred.