The Rapidly Evolving Business of Biosimilars

Biosimilars are to biologics what generics are to pharmaceuticals, still there are some key differences between the two. For instance, production of biologics and biosimilars requires living cell cultures as the starting point for production. Whereas pharmaceuticals and their generic counterparts do not.

Additionally, in order to determine the level of safety and effectiveness of a biosimilar drug candidate, the candidate will be required to undergo a reasonable amount of animal and/or human testing. To decide what constitutes a reasonable amount of testing will depend on the number of similarities between the biosimilar candidate and its innovator or reference product, according to Janet Woodcock, MD, head of the FDA’s Center for Drug Evaluation and Research.

In February 2012, the FDA released a preliminary guide outlining what would be required of companies wanting to break into the biosimilar market. It stated that the makers of these products will be required to present data from analytical studies to show how similar their biosimilar product is to the original FDA-approved biological reference product.

“These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers, said Woodcock. Groundbreaking innovations like biosimilars are something we want to get behind. We want to bring researchers and manufacturers together to help propel advancement.”

Still, one problem that plagues the biologic and biosimilar markets is immunogenicity – a patient’s antibody reaction to a biological drug which the body perceives to be a foreign micro-organism or virus. This is a problem that does not present itself in pharmaceuticals because they are not produced from living cell cultures. Although the generic versions of pharmaceuticals can differ slightly from the reference product they are more easily produced due to the nature of their small molecules. Biosimilars on the other hand, have to mimic the high molecular complexity found in biologics which also carry the added trouble of being an unstable living cell. Furthermore, the body must accept biologics and biosimilars as genuine to the recipient’s system. At this time producing precise duplications of the active ingredients contained in a biologic would be a kin to cloning; thus biosimilars are as “similar” as current scientific production allows.

Moreover, there is always the added difficulty of attracting patients to participate in biosimilar clinical trials. Especially where serious diseases are concerned, patients often are reluctant to participate in clinical trials due to the uncertainty about which product they will be receiving – the unapproved biosimilar or the approved and branded biologic.

Of course, biosimilars follow a business model that aims to produce copies of the originals at a fraction of the cost, and then to offer the resulting products at a lesser price than their original counterparts. And, while this is a window of opportunity to help save more lives by offering the medication at a more affordable price, it is also an opportunity to take advantage of the potentially big business of biosimilars.

“The great economic advantage of biosimilars is that a manufacturer only needs to recreate the idea that has already been shown to work,” said Joseph Miletich, MD, PhD, Amgen’s senior vice president of R&D.

As with any subset of the medicine producing industries,

Competition within the biosimilar industry is expected to be fierce. It is already apparent that larger, well-established companies will be most likely to dominate the market and alliances will likely become even more important in an effort to offset some of the risk and uncertainty that comes along with the new advancement and industry. This is especially important when you consider that the market has not yet grown as fast as expected. Luckily, the overwhelming public demand for lower healthcare and drug costs, as well as the increasing availability of such lifesaving drugs, point to an upswing and growth for the biosimilar market.