This week, Hospira, Inc., a global leader in biosimilars and the world’s leading provider of injectable drugs and infusion technologies, announced the availability of INFLECTRA™ (infliximab) in Canada. This was made possible by a Health Canada approval and will provide the country’s population with an affordable and high quality monoclonal antibody (mAb) biosimiliar therapy for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and plaque psoriasis (Pso).
- Human Monoclonal Antibody Therapy: uses antibodies that are made in the lab rather than by a person’s own immune system. Once the antibodies are given, they may recruit other parts of the immune system to destroy the targeted antigen, such as a cancer cell.
- Biosimiliars: In the US are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA-approved biological product, and have been shown to have no clinically meaningful differences from the reference product.
This announcement comes just a month after Hospira announced that Inflectra™ would be launched in major European markets. An initiative that was undertaken after Hospira released safety and efficacy data from a phase III randomized, double-blind study involving 606 patients with RA and compared their clinical outcomes to patients who were treated with Remicade (source therapy for the biosimiliar), where the findings included:
- 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment, compared with 69.7% treated with Remicade.
- 42.3% of patients receiving Inflectra achieved a greater than or equal to 50% improvement in RA symptoms after 30 weeks of treatment compared with 40.6% treated with Remicade.
- Comparable safety and tolerability data also demonstrated Inflectra’s equivalence to Remicade.
In a press release about the European launch after the trial results, Paul Greenland, Vice President Biologics, Hospira, stated “Inflectra has already been launched in Central and Eastern Europe, and some smaller Western European markets due to earlier patent expiry, and has already been prescribed to treat patients in all its licensed indications. We are delighted that the remaining European countries, including many of the major EU countries, will now benefit from the availability of Inflectra. This supports Hospira’s commitment to provide patients with better access to high-quality, more affordable care.”
For Canadian patients, Hospira has developed an in-depth patient assistance program to help provide infusion-clinic access to qualifying patients across Canada, along with numerous other patient services. These services are furthering Hospira’s mission to bring quality healthcare to patients at affordable prices.
In response to the Canadian announcement, Gerry Stefanatos, corporate vice president, Canada and Australia/New Zealand, Hospira, said “By providing subsequent entry biologic therapies, we can offer patients better access to high-quality, effective treatment options, and can help alleviate some of Canada’s healthcare costs. We are very proud to bring INFLECTRA to Canada — offering physicians, clinicians and patients a treatment option that maintains similar quality, efficacy and safety to its reference product.”
For patients and their providers, these product launches will result in large savings and an opportunity to improve patient access to quality life-changing medications
The name “Hospira” is derived from the words hospital, spirit, inspire and the Latin word spero, which means hope. It reflects our primary market focus and expresses the hope and optimism that are critical in the healthcare industry.
Hospira is the world’s leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare; to improve both the affordability of care for patients and the financial strength of the global healthcare system.
At Hospira, we have the opportunity to Make a Difference every day by positively impacting the lives of our customers and patients and delivering value to all of our stakeholders.
INFLECTRA is indicated for use, in combination with methotrexate, for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. INFLECTRA is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies.
INFLECTRA is indicated for reduction of signs and symptoms, induction of major clinical response, and inhibition of the progression of structural damage of active arthritis, and improvement in physical function in patients with psoriatic arthritis.