Pfizer recently announced that its Inflectra (infliximab-dyyb) for injection will be shipped to U.S. wholesalers in late November. Inflectra is a biosimilar of Remicade (infliximab), and is the first FDA approved biosimilar monoclonal antibody (mAb) therapy that can be used for the same indications as Remicade, including rheumatoid arthritis.
Biosimilar compounds are considered almost identical and interchangeable with another biological drug already approved by the FDA. They are typically more affordable than the original drug and are intended to create competition in the drug market. Biosimilar drug development is supported by the U.S. Patient Protection and Affordable Care Act.
Inflectra is approved to treat rheumatoid arthritis in combination with methotrexate. It can also be used by adult and pediatric patients with Crohn’s disease or ulcerative colitis who failed to respond to standard therapy, and patients with psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
“Biologics have revolutionized the treatment of many life-threatening and chronic diseases. By introducing Inflectra to the U.S. marketplace, Pfizer is helping customers access an additional high quality treatment option that promises greater savings for the healthcare system,” Diem Nguyen, the regional president in North America of Pfizer Essential Health Business, said in a press release.
“We are proud of our global leadership in biosimilars, and will continue our efforts to advance a sustainable, competitive marketplace for these therapies to deliver a high quality, consistent supply of product and long-term savings and value for patients and physicians.” Nguyen said.
Inflectra was initially developed by Celltrion and is approved in 71 countries including Canada and Japan. Hospira, now owned by Pfizer, established an agreement with Celltrion in 2009 for a series of potential biosimilar products including Inflectra. Pfizer holds exclusive commercialization rights for the drug in the U.S. and several other markets worldwide.