Today’s opportunity for Indian companies in biosimilars is not much different from that of the generics industry in 1984. According to Ministry of Commerce and Industry, India’s pharmaceutical export segment has more than doubled from $ 7.8 billion in 2008 to $ 16.5 billion in 2014. With biologic treatments introduced for diseases such as diabetes, cancer, multiple sclerosis, and rheumatoid arthritis, potentially lucrative biosimilar market could emerge as another growth driver of India’s pharmaceutical sector. India has a strong potential to emerge as a key player in the manufacture and marketing of biosimilars.
There are few Indian pharmaceutical companies substantially investing resources towards expanding their biosimilar portfolios. Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, is one of the key players in the forefront of the biosimilar segment and has developed Reditux™, the world’s first biosimilar antibody. Biocon Ltd, which received its first approval for insulin glargine in a developed market (Japan) in March this year, is gearing up to submit application for approval in Europe and the US for its four products in FY17.
To increase global reach and market acceptance of their products, Indian companies are setting up manufacturing base overseas. For example, Biocon has reportedly invested $ 200 million on its just commissioned insulin plant in Malaysia. Similarly, Cipla is investing about Rs 600 crore (Rand 1.3 billion) in the new biosimilar manufacturing facility in South Africa, which the company intends to use to serve local as well export markets such as US, Europe and Asia.
Though biosimilars have emerged as important tool to treat cancer and autoimmune diseases, they are only used by about 8 percent of patients worldwide due to the high costs of these drugs. As more companies join the bio-generics race, prices are likely to fall resulting in higher usage. Although India does not have stringent regulations, it has a big potential for biosimilars. Most innovator biotherapeutics are unaffordable to the average patient in India, even though the price in the local market is usually lower than that in Western countries.
DelveInsight Business Research
Boston Biomedical starts phase III study of Napabucasin
Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, announced dosing of the first patient in CanStem303C, a new global phase III study investigating napabucasin in combination with standard of care (Folfiri) in patients with previously treated metastatic colorectal carcinoma (mCRC). Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.
Martindale Pharma’s clobazam oral suspension receives approval from seven European countries
Martindale Pharma, UK-based international specialty pharmaceutical company, announced the regulatory approval of its clobazam oral suspension product, Epaclob. The suspension has received approval in France, Ireland, Germany and Italy and Silocalm in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP). Epaclob/Silocalm are based on Tapclob, and are approved in two strengths, 5mg/5ml and 10mg/5ml. They will be supplied in packs containing dosing syringes and dosage cups to facilitate accurate dosing and aid adherence to treatment.
Merck snagged a green light for Zinplava
The anti-infectives field is heating up–and Merck’s the latest Big Pharma player to win approval for a new entrant. The medicine meant to reduce resistance of Clostridium difficile infection in adults. Zinplava will join a Merck anti-infectives portfolio that took shape with its early 2015 purchase of Cubist Pharmaceuticals. Zinplava also faces the prospect of competition not only from other drugs, but also from vaccines that might prevent C. Diff altogether. Pfizer and Sanofi are each working on versions, and smaller vaccine makers are in the mix, too.
Nanotechnology to improve HIV drug therapies
Researchers at the University of Liverpool, UK, are exploring the use of nanotechnology to improve administration and availability of drug therapies to HIV patients. A recent investigation conducted by Pharmacologist professor Andrew Owen and Materials Chemist professor Steve Rannard, has discovered that HIV patient groups have shown their desire to switch to nanomedicine alternatives. They are working on the development of new oral therapies, by using solid drug nanoparticle (SDN) technology. The SDN technology is anticipated to reduce both the dose and the cost per dose.
Biocon’s Malaysia insulin plant will be ready for commercial production in H2
India’s Biocon has been working for six years on a massive, $250 million facility to manufacture insulin in Malaysia and says it will soon produce commercial product there. The company’s plant is in Nusajaya, which was certified by authorities this year, and has 400 employees and represents the largest foreign investment made in Malaysia’s biotech sector to date. It also is Biocon’s first overseas biopharma manufacturing and research facility.
Clinicians have been conducting biopsies for a long time, for diagnosing and managing cancer, as genetic profile of tumor is analyzed through biopsy. Tissue biopsy is a traditional biopsy technique which is a time consuming and lengthy procedure, and cannot be performed routinely. Liquid Biopsy is a next generation cancer test which is an alternative to tissue biopsy. It helps in early detection of various cancers such as Breast Cancer, Ovarian Cancer, Prostate Cancer and Colon Cancer as it detects mutations in fragments of tumor DNA and tumor cells.
Liquid Biopsy is recommended for monitoring treatment response, genetic changes and resistance mechanisms in the tumor. It provides complete genetic information of genes such as Epidermal Growth Factor Receptor (EGFR) and Serine/threonine-protein kinase (BRAF) expressed on various cancer cells. It is based on Polymerase Chain Reaction (PCR) amplification or Next-Generation Sequencing (NGS) technology, and involves analysis of genetic markers such as Cell Free DNA (cfDNA) and Circulating Tumor Cells (CTCs) for tumor detection. It also detects more than two mutations that can occur in some cancers such as Melanoma and Lung Cancers, which is an advantage over tissue biopsy as the latter fails to detect two to four genetic mutations.
The process involves three step procedure including phlebotomy, separation of plasma cells from blood, isolation of cfDNA and analysis of cfDNA. It provides high positive predictive value, is safe and easy to perform and provides complete tumor genetics of a patient.
Several liquid biopsies tests have been approved. Among them, Cell Search test developed by Veridex was the first liquid biopsy screening test to be approved in China in 2012 for diagnosis of Breast Cancer. In 2015, CancerIntercept developed by Pathway Genomics was approved. Recently, Cobas EGFR Mutation Test V2 developed by Roche was approved by USFDA in 2016 for diagnosis of Non-small cell lung cancer (NSCLC). Several Companies such as San Diego, OncoCyte Corp, Myriad Genetics and Veracyte are developing liquid biopsy tests, while IIlumina, Guardant Health and Inivata are raising funding for the development of liquid biopsy tests.
Insight by: Diksha Wadhwa
DelveInsight Business Research