Why Biosimilars?And why now?

Graeser Associates International

Biosimilars, or follow-on biologics, are generic versions of

biological drugs, which are proteins. Biosimilars are approved in

reference to the originator biological drug, or reference product.

They are required to undergo a process of regulatory approval in

order to ensure that they are sufficiently similar to the reference

product in order to be safe and effective.

Currently, biosimilars are sold

throughout Europe; the process of

reviewing and approving such follow-on

biologics has recently started in the US

under the BCPIA (Biologics Price

Competition and Innovation Act of

2009).

• The main answer to the question of why biosimilars are

important now relates to cost. Typically, biosimilars sell for

70% of the cost of the originator drug. Given the expense of

many biological drugs (some of which cost $100,000 per year

per patient), cost savings of 30% can be very attractive for

those paying for such biological drugs – whether private

insurance companies, the government or private individuals.

• Furthermore, the need for biological drugs is expected to

increase with an aging population; some biological drugs, such

as Humira® (Adalimumab) by Abbott, specifically target

diseases, such as rheumatoid arthritis, that are more prevalent

in older populations. Thus, the overall amount spent on

biological drugs is expected to continue to rise.

• However, biosimilars represent many unique challenges in comparison to generic small molecule drugs. For example, because biological drugs are manufactured by living cells, different manufacturing processes may in fact lead to different proteins being produced; even if the amino acid sequence of the protein is identical to the originator biological, the biosimilar protein may have different post-translational modifications, which may in turn lead to different effects in the patient.

• Immune related side effects are of particular concern. The approval process for biosimilars is different from that of generic small molecules with regard to trade secrets, patents and other aspects of intellectual property. Finally, many originators, such as Abbott, are even challenging the validity of biosimilars in the US.

• In our next blog posts, Graeser Associates International will be

exploring these different challenges and uncertainties of

biosimilars in the US, both with regard to intellectual property

but also with regard to hospital pharmacists, who will be at the

front line of much of the uncertainty for providing biosimilars

to patients.

• We will also be providing powerpoint presentations, written

reports, and short audio and video presentations through our

Slideshare channel. We will also be selling more detailed

reports and longer audio and video presentations – please see

our biosimilars product page for a list of products

• D'vorah Graeser, PhD is the founder and

chief executive officer of Graeser Associates

International (GAI), an international health

care intellectual property firm. Dr. Graeser

has been a U.S. patent agent for over 15

years and has extensive experience in the

biomedical field. Follow Dr. Graeser on

Twitter: @DGraeser. Follow our biosimilar

communications on Twitter: @GAI-

biosimilars. Email us at biosimilars@gai-

ip.com.