List of Biosimilars Companies in India - 13

Bharat Serums And Vaccines Limited (BSV) is one of the fastest growing biopharmaceutical companies in India. For 50 years now, BSV has used its scientific resources to develop a range of biological, biotech and pharmaceutical products. Today, as we influence patient outcomes in the therapeutic areas of Women’s health and Critical Care and IUI-IVF, we have the privilege of being a partner of choice. BSV's product portfolio includes plasma derivatives, monoclonals, fertility hormones, antifungals, anaesthetics, cardiovascular drugs, and equine immunoglobulin /antitoxins. In addition, BSV offers products in the areas of gynaecology, assisted reproductive technology, critical care, emergency medicine, neurology, nephrology, haematology, and urology. The company provides its products to retail outlets and hospitals through distributors primarily in India, as well as in the Asia Pacific, the Russian Federation, CIS countries, Latin America, Africa. BSV is amongst the top 10 Biotech companies in India. The Company has in its portfolio over 145 brands. The company has over 1000 employees selling its products across the country. Our brands are marketed all over India and exported to over 70 countries across the world We have an open and entrepreneurial culture, with each of our employees taking on significant responsibility in each activity of our value chain, be it in terms of research & development, manufacturing, quality, sales & marketing, distribution, business development or organisation building. Advent International, a global private equity firm has endorsed its faith in our commitment towards bringing life to life

Biocon: Enhancing Global Healthcare Biocon Limited, publicly listed in 2004, is India's largest and fully-integrated, innovation-led biopharmaceutical company. It is an emerging global biopharmaceutical enterprise serving customers in over 120 countries. Driven by a vision to enhance global healthcare through innovative and affordable biopharmaceuticals, we have enabled access to advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high. The early anticipation of the increasing dominance of biologics in global development pipelines helped us to be ahead of the curve in crafting a differentiated product portfolio based on fermentation and recombinant technologies, which straddles fermentation-derived small molecules and biologics, both novel as well as biosimilars. The significant brand equity that we have built worldwide for our small molecule APIs across statins, immunosuppresants and other specialty products has made us a leading global supplier of these products. We have also built one of the largest and most diverse biosimilar pipelines, spanning insulins, monoclonal antibodies and other recombinant proteins that address critical chronic diseases such as diabetes, cancer and autoimmune disorders. Ranked among the Top 3 biosimilar players globally for rh-insulin and insulin glargine in volume terms, we are the first Indian company to launch a biosimilar in Japan with Insulin Glargine, which also has been approved for sale in EU and Australia. Our insulin products have made a difference to the lives of millions of people with diabetes across the globe. We now aim to provide our insulin products to ‘one in five’ people with diabetes in need of insulin-based therapy anywhere in the world within the next 10 years. We are also making a huge impact in the area of cancer care. Our biosimilar Trastuzumab, which was the first to be approved anywhere in the world and launched in India in 2014, has helped treat several thousand HER2-positive metastatic breast cancer patients. We are also the first company from India to get its biosimilar approved by the USFDA; Ogivri™, co-developed by Biocon and Mylan, is the first biosimilar Trastuzumab to be approved in the US. In addition to Trastuzumab, several of our biosimilar assets are on track for anticipated regulatory approvals in developed markets. We are also developing a pipeline of patented biologics to address global unmet medical needs. We have successfully launched a couple of novel biologics in India: Nimotuzumab for the treatment of head and neck cancer and Itolizumab to tackle psoriasis. Besides these, we have a basket of novel assets are under various stages of clinical development, including a high potential oral insulin. Through our subsidiary, Syngene, we offer a suite of integrated, end-to-end discovery and development services for novel molecular entities (NMEs) to the global life sciences sector. Ranked by the prestigious Science magazine among the Top 10 Best employers in the biotech industry, Biocon is passionately pursuing a mission to rationalize healthcare spends, enhance access to life-saving therapies and make a significant impact to global healthcare through ‘blockbuster’ drugs with the potential to benefit a billion patients.

Later part of the bygone twentieth century has witnessed a major revolution in the field of life-sciences. Researches carried out during this period, particularly in the area of molecular biology and recombinant technology, have led to emergence of 'Biotechnology'​ with a new face. Plants, animals and microorganisms being a key component of our ecosystem have always remained at centre-stage of research for different purposes as they affect the human life. Development of culture methods, better understanding about molecular biology, discovery of restriction endonucleases and their use in mapping of DNA laid the foundation stone for modern day biotechnology. Isolation of thermostable DNA polymerase along with the development of PCR technique made cloning simplified and providing way for rec-DNA technology. Further developments were generation of bar-code like DNA fragment patterns of genomic DNA. These patterns appeared useful in distinguishing individuals based on DNA sequence variations among them. Such variations of DNA among organisms were termed as fingerprints or profiles which provide a versatile tool to characterize genetic variability, genome evolution, population genetics, taxonomy, breeding and diagnostics even today! The technology to read the DNA base-by-base made it possible to identify useful genes. This information which could be cloned in suitable vectors and introduced in appropriate hosts through a variety of gene transfer methods gave an impetus to genetic improvement programmes and production of Genetically modified organisms. Today the genomic sequencing is contributing to identify the basis of pathology, providing tailored therapies. We are quickly advancing towards the in situ engineering of the genomic information to achieve designer humanity. Bioheaven ventures into this space "Turning Human Needs into Careful Solutions"​..........

CLONZ  is a biopharmaceutical firm promoted by a group of young and passionate Biotechnologists, focused on the development, manufacturing and commercialization of Human Therapeutic  biosimilar Monoclonal Antibodies (MAbs).   Clonz got incorporated in 2009  and started its operations in September 2010 at Genome Valley, Hyderabad, India With experienced team coming from recognized leaders in recombinant biosimilar manufacturing, Clonz is committed to delivering quality biologics to make treatment and care affordable to the world population in many disease indications, with special emphasis on Oncology. DSIR (Govt.of India) Recognised R&D unit with fully integrated Mammalian platform to Develop Biosimilar MAbs

Epygen Biotech private limited is a Biotechnology organization promoted by the founders of Epygen Labs, bringing along decades of precious experience in Biotech research and successful business. With offices, labs and manufacturing facilities in Dubai, India and USA, Epygen Biotech exhibits unique capabilities in the Biotechnology field, where it has developed a strong pipeline of therapeutic proteins for Cardiovascular, Oncology and Immune disorders. With focus on Biosimilars and Novel Biologic Entities, Epygen utilizes its skills in molecular biology, fermentation and protein engineering to produce Biologics in an affordable way, meeting global regulatory standards.

GeneSys Biologics was established in Nov 2014 by a group of like-minded individuals with strong global experience in development of biosimilars. A science-based biosimilar company with the vision of becoming one of the leading global biopharmaceutical companies in the world. GeneSys aims to expand market access across the globe by providing affordable and high quality biosimilars.

Gennova Biopharmaceuticals Ltd. is a biotechnology company based in Pune, Maharashtra, India. The company specializes in the research, development, production, and commercialization of biotherapeutics and vaccines aimed at treating life-threatening diseases in areas such as cardiovascular, neurology, nephrology, and oncology. Gennova employs advanced recombinant DNA technologies and innovative bio-manufacturing practices to create effective biotherapeutic solutions. The company utilizes various expression platforms, including bacterial, mammalian, and yeast-based systems, to produce its recombinant products. Gennova has successfully commercialized seven products, including Tenectase, a biosimilar for treating Acute Ischemic Stroke, and HAMSYL, a treatment for acute lymphoblastic lymphoma offered at a lower price point for better accessibility. With a strong focus on research and development, Gennova is recognized as a preferred partner in the vaccine sector for research and cGMP manufacturing. The company employs around 598 people and has reported a revenue of $2.8 million, positioning itself as a notable player in the Indian biotechnology landscape.

Lazuline Biotech Private Limited is a research-driven and quality-focused biomanufacturer with a focus on improving the human health by catering to the needs of the healthcare and biopharma industries. Our world-class R&D and cGMP manufacturing facility in Hyderabad, India has enabled us to develop a range of Recombinant and Biological products. Founded in 2011, through the years we have been able to differentiate ourselves with our product-oriented focus and global partnerships. Through continuous innovations and single-pointed focus, we are proud to be producing the highest capacity in the world at economical pricing for the global market.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Panacea Biotec is a research-based health management company involved in research, manufacturing and marketing of high-quality, affordable pharmaceutical, vaccines and herbal products. The product portfolio includes highly innovative prescription products in important therapeutic areas like pain management, diabetes, cardiovascular, renal disease management, osteoporosis, gastro-intestinal care products and vaccines. Panacea Biotec is committed towards disease prevention by introducing Innovative Vaccines that helps to reduce child mortality. Our portfolio consists of worlds first fully liquid Hexavalent vaccine i.e. EasySix (DTwP-Hib-HepB-IPV), the world’s first fully-liquid Pentavalent vaccine i.e. Easyfive-TT (DTwP-Hib-HepB), Oral Polio vaccines (like bOPV, tOPV, mOPV), etc. We have a high-impact pipeline of vaccines including Pneumococcal conjugate vaccines (PCV), tetravalent dengue vaccine, etc. We have supplied 10+ billion immunizations of Polio vaccines in last 20 years, 150+ million immunizations of Novel Innovative fully liquid wP-based vaccines like the wP-Hexavalent vaccine (DTwP-Hib-HepB-IPV). And are a trusted partner for WHO, GAVI and UN Agencies with track-record of sustainable supplies for UNICEF, PAHO, and National Immunization Programs. In Pharmaceuticals, we have discovered and commercialised a NCE, Sitcom – that helps in Haemorrhoids and Piles. It is the leading brand in its segment in India and many other countries. We also have built leading brands like Pangraf, Mycept, Glizid, Livoluk, and PacliAll across transplantation, diabetes, constipation, and oncology. Our facilities are WHO Prequalified, US FDA approved and cGMP compliant. Our products are available across more than 145 countries including US, Germany, among other markets.

Reliance Life Sciences is a medical biotechnology-led company engaged in research and development, manufacturing and marketing of differentiated medical products and services, used to treat patients primarily in intensive and critical care units in hospitals. Our core businesses are plasma proteins, biosimilars, and later generation oncology pharmaceuticals. In addition, we have initiatives in clinical research, molecular medicine, regenerative medicine, gene therapy, peptides and oligonucleotides.

SciGen is a rapidly growing biopharmaceutical company that markets and commercializes innovative and affordable healthcare products worldwide. We leverage our commercialization and networking capabilities to in-licenses and distribute branded pharmaceutical products and medical devices to treat endocrinological and oncological diseases, and continuously fill and improve our pipeline and product portfolio. Founded in the Asian Innovation Capital, Singapore in 1988, we currently have operations in Singapore, South Korea, Australia, China, Philippines and present commercially in all 6 continents. With the exceptional commercialization capabilities, regulatory expertise as well as international management experiences, and strategic partnerships built with industry and academic institutes, we strive to deliver hope and make a real and lasting difference to patients and their families. Who are we? - We believe in delivering solutions that matter to the people of today and innovating for the people of tomorrow. - To us, it is more than a business - it is a mission. What do we do? - We combine a specialty pharmaceutical business with a leading biologics biotechnology engine. - We partner to bring the best drugs we can find to the patients who need it most. How do we do it? - Our efforts aim to deliver better patient outcomes through better science. - We understand that humility and service matter as it is not about us, it is about making patients’ lives better.

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is a prominent global pharmaceutical company based in India. Established in 1983, it has grown to become the largest pharmaceutical company in India and the fifth-largest specialty generic pharmaceutical company worldwide. Sun Pharma specializes in generic and specialty pharmaceuticals, focusing on chronic therapies in areas such as cardiology, psychiatry, neurology, gastroenterology, and oncology. The company operates in over 100 countries, with significant markets in the U.S., India, and emerging economies. Sun Pharma produces a diverse range of off-patent generic drugs, including tablets, capsules, injectables, and topical formulations. It also develops complex generics and specialty products for various conditions. The company has a strong commitment to research and development, investing in novel drug delivery systems and biosimilars. With 43 manufacturing facilities across five continents and a workforce of over 37,000, Sun Pharma continues to expand its global footprint and enhance its product offerings.