The second quarter is expected to be rife with news regarding Food and Drug Administration approval decisions on a biosimilar for rituximab and two pending applications for trastuzumab. Although biosimilars have not generated much news of importance lately, we wrap up the week with some items of interest.
First, Celltrion estimates that it will conclude a phase 1 pharmacokinetics trial of its infliximab biosimilar (Inflectra®) in a new subcutaneous route by July 2018. This could potentially be important, if successful, because Inflectra, the originator product Remicade®, and Renflexis® are only available for administration through intravenous infusions (normally at the physician’s office, given over the course of multiple hours). One of the attractions of other anti-TNF products for use in Crohn’s disease and other immunologic disorders (e.g., adalimumab, ustekinumab) is the availability of subcutaneous autoinjectors or prefilled syringes, allowing it to be given at home, and much more rapidly. This could potentially widen the infliximab market a bit.
Second, Mylan announced an agreement with the California-based company Revance Therapeutics to develop and commercialize a biosimilar form of onabotulinumtoxin A or Botox®. The popular injectable botulinum toxin derivative has been used since the 1990s for cosmetic indications as well as for muscle spasms and even for the prevention of chronic migraine. Interestingly, Revance, a biotech development company, is currently focused on another neuromuscular modulator, daxibotulinumtoxinA, principally for cervical dystonia (phase 2) and plantar fasciitis (phase 1).
Finally, the New England Journal of Medicine published a biosimilar blooper on Wednesday, when author Richard G. Frank, PhD, of the Department of Health Care Policy, Harvard Medical School, attempted to provide some perspective on the slow availability of biosimilars in the US. He wrote that 7 biosimilars were now available for use; this of course is a misstatement. Nine biosimilars have been approved for use in the US but only 3 (2 for infliximab) were actually marketed. Surprisingly, this made it past the N Engl J Med reviewers and editors. Dr. Frank also emphasized that “secrecy about manufacturing processes” was a significant barrier; however, this is probably less a problem than prospective biosimilar manufacturers trying to obtain samples of the reference product for characterization and comparison during preclinical and clinical development.