Biosimilars are very much a hot topic of late. They are approved new versions of innovator biopharmaceutical products, following patent expiry. Essentially, this is like a generic version of the biologic product, hence their alternative name, follow-on biologics.
Recently, the FDA approved the Momenta/Sandoz’s follow-on versions of sanofi-aventis’s Lovenox, a low molecular weight heparin (LMWH), used to prevent and treat deep vein thrombosis or pulmonary embolism. The patent expired in July 2010 and approval was given on July 23rd. Reports in the press suggest that erosion of the brand was both fast and steep, with a 60% shift in market share to the cheaper versions almost overnight.
At present, the FDA doesn’t have a recognised approval system for follow-on biologics, so the process is somewhat fuzzy. I’m not sure why the FDA approved Momenta’s versionof enoxaparin, but not Teva or Amphastar’s, although inevitably, there was a lot of noise surrounding the issue in the press over the last year. I’m not going to go into the details of the shenanigans over this, but a quick Google search will offer more information than many will have time to read!
What was interesting to me was that Momenta scientists published an interesting paper in Nature Biotechnology (reference below) on Chinese hamster ovary (CHO) cells. CHO cells are the most common cells used to synthesise recombinant proteins used in many drugs and are extremely well studied. Previously, however, CHO cells were thought to lack the biosynthetic ability necessary to synthesize a particular glycoprotein, but the Momenta scientists found otherwise, underlining their expertise and research in this field.
These players – Momenta, Sandoz, Teva and Amphastar – probably have the lead in follow-on biologics for now, so they will be interesting companies to watch out for as the patent cliffs in biologics begins to hit big Pharma between now and 2015.
Now, while the FDA still doesn’t have any official regulations for follow-on biologics, the European Medicines Agency (EMA) has begun to tackle the issue head on, posting draft guidelines last week. You can check them out online. According to the EMA:
“The Agency has released the draft guideline on similar biological medicinal products containing monoclonal antibodies for a six-month consultation period.
The guideline lays down the requirements for medicines containing monoclonal antibodies that claim to be similar to another such medicine already marketed.
Comments on the draft guideline can be submitted to the Agency up to 31 May 2011.”
Unfortunately, I haven’t had time to digest the EMA proposals yet, but we will post a full synopsis in a future blog post soon.
If you have any thoughts, comments or questions, please feel to add them in the comments below.
Bosques, C., Collins, B., Meador, J., Sarvaiya, H., Murphy, J., DelloRusso, G., Bulik, D., Hsu, I., Washburn, N., Sipsey, S., Myette, J., Raman, R., Shriver, Z., Sasisekharan, R., & Venkataraman, G. (2010). Chinese hamster ovary cells can produce galactose-α-1,3-galactose antigens on proteins Nature Biotechnology, 28 (11), 1153-1156 DOI: 10.1038/nbt1110-1153