Biosimilar is a bio-therapeutic drug that is similar in terms of safety, quality, and efficacy to an existing therapeutic drug. Biosimilars are a class of therapeutic drugs that provide additional treatment options and help reduce healthcare costs. They are almost identical to an existing therapeutic drugs and can only be manufactured when the patent for the original innovator drug expires.
Remicade biosimilars are used for the treatment of various autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, chronic severe plaque psoriasis, ulcerative colitis, Crohn's Disease, rheumatoid arthritis, etc. The number of biosimilars currently approved by the FDA is twenty-eight.
Market Dynamics
Increasing demand for biosimilar drugs and increasing incidence/prevalence of autoimmune diseases such as rheumatoid arthritis and plaque psoriasis is expected to propel the remicade biosimilar market growth. For instance, more than 24 people in the United States (more than 7% of the population) suffer from an autoimmune disease, and the prevalence is rising. Autoimmune diseases are a family of more than 80 chronic, often debilitating and, in some cases, life-threatening illnesses.
Moreover, increasing research and development activities and speedy approvals by regulatory authorities for biosimilars, especially in North America, are expected to aid in the growth of the remicade biosimilar market. For instance, in December 2019, Amgen received the Food and Drug Administration (FDA) approval for AVSOLA (infliximab-axxq) for the treatment of ankylosing spondylitis, psoriatic arthritis, chronic severe plaque psoriasis, ulcerative colitis, Crohn's Disease, and rheumatoid arthritis.
However, complexities in manufacturing and stringent regulatory requirements are expected to hamper the growth of the remicade biosimilar market.
In terms of geography, Europe is expected to witness substantial growth in the remicade biosimilar market due to the high adoption rate due low price of the biosimilars, the presence of top market players, and rapid entry of biosimilars in the region. For instance, in May 2018, Sandoz received European Commission (EC) approval for Zessly (infliximab), a remicade biosimilar for use in Europe.
Competitive Analysis
Major players operating in the remicade biosimilar market are Napp Pharmaceuticals, Nippon Kayaku, Pfizer, Alvogen, Merck and Company, Janssen Biotech, and others.
Key players active in the market are focused on introducing novel remicade biosimilar for multiple indications to strengthen their market position or to strengthen their product portfolio. For instance, in 2017, Merck and Company and Samsung Bioepis jointly introduced Renflexis (infliximab-abda), a remicade biosimilar to treat moderate to severe rheumatoid arthritis, active ulcerative colitis, Crohn’s disease, and other few disease indications.
No comments:
Post a Comment