March 2, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO – Rheumatoid arthritis (RA) is the most common form of autoimmune arthritis. It’s a painful affliction affecting the hands and joints, and there are numerous treatments, such as Genentech ’s Rituxan or AbbVie ’s Humira, that provide tremendous relief to patients. However, those medications may soon find fierce competition with a new slate of biosimilar drugs in development by a number of pharmaceutical companies.
Although there is no cure for RA, advances in biologics, such as Rituxan, or anti-tumor necrosis factor (TNF) biologics like Humira are widely prescribed to help alleviate the symptoms and allow patients to lead productive lives. Genentech has built a solid RA pipeline around Rituxan over the past 10 years and continues to push new therapies in the market. Rituxan was the first selective B-cell therapy approved by the U.S. Food and Drug Administration for the treatment of adult patients with active RA.
However, a new day may be coming for expensive RA therapies with the nearing approval of biosimilars. Biosimilars, which are made inside a living cell, are always a little different in composition than the biologic they are attempting to copy. In that sense, biosimilars are different than generic drugs, which are exact replicas of other small molecule drugs.
Biosimilar drugs have been widely available in Europe since 2006. Last year Sandoz, a subsidiary of Novartis AG , won approval for the first biosimilar drug in the United States, a version of Amgen’s Neulasta, called pegfilgrastim, which is used to fight infection in cancer patients.
Several companies are moving forward with biosimilar candidates for RA, including Amgen, which is developing a biosimilar for AbbVie’s Humira. In Oct. 2015, Amgen, which makes the RA treatment Enbrel, announced positive Phase III results for ABP 501, a biosimilar to Humira (adalimumab) in patients with RA. The FDA is expected to review the drug for approval by Sept. 25, 2016.
In February the FDA’s Arthritis Advisory Committee recommended approval of all eligible indications for Celltrion’s CT-P13, a proposed biosimilar to Janssen Biotech’s Remicade (infliximab), by a vote of 21-3. CT-P13 is the first biosimilar monoclonal antibody (mAb) medication to be considered by the FDA, the company said in a statement. Celltrion is seeking approval of CT-P13 for the treatment of a variety of serious autoimmune diseases, including Crohn’s disease, ulcerative colitis and RA, among others. Celltrion said it expects the FDA to make a final decision in April. If approved, Pfizer would assume commercialization rights for the medication in the United States under the proposed brand name, Inflectra, Celltrion said.
Boston-based Biogen and Swiss-based Samsung BioLogics recently received approval from the European Medicines Agency for Benepali, the first etanercept biosimilar referencing Enbrel to be approved in the EU. Benepali has become the first subcutaneous anti-TNF biosimilar available there. Anti-TNF’s are the largest component of the EU biologics market, accounting for approximately $10 billion of all biologics sold there, Biogen said in a statement.
In Korea, Samsung Bioepis gained the approval of Renflexis, a biosimilar version of Remicade (infliximab), also known as SB2—for the treatment of RA, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. Renflexis is the second RA biosimilar for Samsung Bioepis. In September 2015, the company also received Korea’s Ministry of Food and Drug Safety approval for Brenzys, a biosimilar of Enbrel.
Just like traditional drugs, not all biosimilars will make it to market. In October 2015, Germany-based Boehringer Ingelheim Pharmaceuticals halted clinical development for its biosimilar version (BI 695500) of Roche’s blockbuster leukemia treatment Rituxan/MabThera (rituximab).
While biosimilar drugmakers are finding a toehold in the U.S., traditional RA treatments will continue to be developed by companies such as Genentech. In addition to Rituxan, Genentech is also pushing forward with new RA therapies, such as late stage trials for investigating Actemra for the treatment of giant cell arteritis and investigating the use of Rituxan for the treatment of pemphigus vulagris.
