Recently, FDA (Food and Drug Administration) has enlarged the potential application of mAb (Monoclonal Antibody) therapy for inhibitory use, which are at serious risk due to a confirmed exposure to the virus. The permission was based on a substantial clinical trial that found the antibodies averts symptoms in a household contact of people who recently tested positive.
The FDA pressured that the therapy is not a substitute for vaccination. The most common question people ask around the globe is about monoclonal antibody therapy for covid-19. With the global surge in getting monoclonal antibody therapy, specific eligibility criteria are to be considered.
Monoclonal Antibody Therapy, also known as monoclonal antibody infusion treatment, is a way to treat the coronavirus or covid-19 t. These monoclonal antibodies COVID therapy aims to neutralize the virus thus decreasing the viral burden and minimizing the severity of the disease.
Monoclonal Antibody has been widely used to treat various cancers and autoimmune diseases. Adalimumab is an Anti-Rheumatoid Antibody Drug molecule which is considered as blockbuster molecule and has the biggest sale around the world. Currently, Antibody has wider scope in Infectious disease, Hence Monoclonal Antibody therapy could be a boon for epidemic diseases like COVID or any other future outbreak.
Why Monoclonal Antibody Therapy?
Antibodies have proven to be a mega-blockbuster class of drugs with multi-billion growth prospects. These have been now widely accepted for the treatment of chronic disorders; the further regulatory path for product approval has been established. New technology developments (humanization, Fc engineering) have facilitated product life cycle management. Out of 453 molecules, currently in development both in pharma and biopharma 215 are MAbs. Antibodies constitute 20% of marketed biologics, 60% of products that are in clinical development and 70% of molecules in pre-clinical development stages. Major application areas have been cancer (70%), Inflammatory diseases (20%) and infectious diseases (10%).
Big pharmaceuticals are trying to derive 40-65% of their pipeline from antibodies and other biologics through one or the other following strategies to acquire MAb development capabilities.
- Acquisition: Astra Zeneca- CAT and MedImmune, Amgen- Immunex and Abgenix, Johnson & Johnson- Centocor, Roche- Genentech and Tanox, Merck- Glycofi, Pfizer- Wyeth etc
- Late stage Product In-Licensing: Bristol Meyers –Erbitux (Imclone), Novartis- Xolair and Lucentis (both Genentech). Currently, GSK and Vir have received binding agreements for the sale of approximately 1.7 million doses of sotrovimab (Anti-COVID Monoclonal Antibody therapy) worldwide
- Broad R and D collaboration: Takeda-Amgen, Aventis- Immunex/ Regeneron, and Pfizer- Medarex.
Biosimilar Antibody Development
There are 40 marketed MAbs approved for various therapeutic indications, of these few are blockbuster molecules with annual revenues crossing >US$ 20 billion, significant among these are – Rituxan (Anti CD-20) for treatment of non-hodgkins lymphoma, Herceptin (Anti Her2) for treating breast cancer, Avastin (Anti-VEGF) for treating head and neck cancer, Erbitux (Anti-EGFR) for treating colon cancer and Humira (Anti TNF alpha) for treating rheumatoid arthritis.
Final Word
With the emerging increase in the monoclonal antibodies therapy getting FDA approval as Life Saving drug, the Antibody as a magic bullet can be widely used where treatments are not available. The aim to find a drug against a novel target can be started from the discovery of antibodies against the target.
We at Genext Genomics create biologics and provide high-quality Monoclonal Antibodies for the facilities to continue their research and development to bring out a greater good. With our team of experienced professionals and expert scientists, we cater to every industry’s needs and deliver them at competitive market prices.
With our attempt to make the Antibody Biologics Production more high-quality and bring them to the market at the correct prices, we discover antibodies for drug purposes from our efficient Antibody library platform. Work with us to discover your next blockbuster drug molecule and serve society.