The next frontier of biologic drug manufacturing lies on biosimilars, or so it seems. The lucrative market of biologics or biopharmaceutics will soon be opened up to generic companies as IMS forecasted that $48 million dollars’ worth of these medicines will lose their patents in the coming years. In 2015, U.S. FDA approved the first biosimilar, Zarxio, which is a knockoff drug of the original filgrastim (Neupogen) by Amgen Inc.

Pharmacists are expected to play an important role in the imminent arrival of the biosimilar era. However, the appropriate keyword to describe the current situation of biosimilars, both internationally and in the local setting, is "uncertainty".

The approval process of biosimilars, relevant legislation regarding interchangeability of biologics and pricing mechanisms are still subjected to continuous modification. As such, it is not surprising to find many misconceptions regarding biosimilar products when the field itself is still shrouded in mystery. Here we will look at the 4 most common misconceptions encountered in biosimilar.

1. Biosimilars are the same as generics

Biosimilars and generic drugs share many similarities. Both types are related to the production of a reliable copy of a drug that has gone off-patent.

However, at the core of biosimilar one may find many distinctions with generic: a biosimilar product typically refers to biologics with complex molecular structure and are challenging to replicate in their entirety while generics are small chemical entities that are easy to synthesise. Therefore, legislative requirements imposed on manufacturers to testing, producing and registering biosimilars are entirely different to that of generics.

2. Biosimilars have a long history

Many healthcare professionals who are inexperienced in the field of biosimilars may have the erroneous impression that biosimilar products share the same historical timeline as generic medicines, owing to many misunderstanding that both terms refer to the same thing.

In fact, the European Union legal framework for evaluating and approving biosimilars was only established in 2003, and the relevant guideline for such approval was not developed until two years later.

The European Medicines Agency (EMA) is the only regulatory body that has the authority to grant approval to a particular biosimilar product. In 2006, Omnitrope (somatropin), manufactured by Sandoz, was the first biosimilar to receive marketing approval in the EU. Till date, the EMA has approved a total of 31 biosimilars, of which two of them were subsequently withdrawn leaving 29 products currently approved for use. In the U.S., the first biosimilar product was approved in 2015.

3. Biosimilars are manufactured similarly as generic drugs

The molecules of biosimilar products are generally larger and more complex than the simple chemical compound of generics. The complexity and the resultant superior efficacy of biologics have, unfortunately, also render these molecules difficult to reproduce.

To replicate a biologic successfully, the manufacturers have to resort to using living cells to synthesise these large proteins as it is impossible to produce them via a conventional chemical process. Nonetheless, variations in the biosimilar production are inevitable which will lead to minor differences in protein structure, molecular weight or the three-dimensional folding of the molecule. These differences cause considerable controversies and concerns when it comes to the biosimilar approval process as these will impact patient safety directly.

4. Biosimilar products are freely interchangeable with their reference biologics

As described above, biosimilar products are expected to differ, to a certain extent, with each other regardless of how tightly controlled the production procedures are. As such, additional cautions are warranted when it comes to interchanging one biologic product with its biosimilar.

U.S. FDA has published the List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, otherwise known as The Purple Book, to guide pharmacists and physicians in determining if two products are interchangeable. MIMS

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Sources:
http://marketrealist.com/2016/03/patent-cliff-driver-generic-drugs-growth/
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp&mid=WC0b01ac0580281bf0
http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
https://www.forbes.com/sites/kpmg/2016/07/13/biosimilars-a-new-remedy-for-rising-prescription-drug-costs/#4e36f4eb4e05
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.specialtypharmacytimes.com/contributor/andrew-abe-pharmd/2015/09/biosimilars-a-review-and-requirements-for-pharmacists/