A biosimilar is a copy of an original authentic product redesigned by a different company only after the patent of that biologic’s formula is no longer protected

A biosimilar is a copy of an original authentic product redesigned by a different company only after the patent of that biologic’s formula is no longer protected, multiple companies can release a drug with the same chemical formula, so that the cost decreases, that new biologic drug is a biosimilar. Patents of biologic drugs of major pharmaceuticals companies, such as Lantus,Remicade, Rituxan, Herceptin, Enbrel, and others have expired recently and in the coming decade, Patents for many branded biologics will expire during the next few years such as Erbitux, Avastin, Orencia, and others, which would provide the accessibiliy of biosimilars because these agents are expected to improve affordability and promote wider and earlier access to critical, often lifesaving therapeutic interventions. Ideally, the FDA’s finalized guidelines will establish a regulatory path for biosimilars that will ensure patient safety, control development costs, and encourage innovation by manufacturers an opportunity for many new companies as well as generic manufacturers to offer services, specially tailored toward biosimilars. The global biosimilar market has been valued to be 3,474.01 million USD in 2017, and is expected to rise at the CAGR of 43.85% during the period of next 5 years (2018-2023). North America has been predicted to account for the largest share of approximately 30% of the global market, in 2017, while Asia-Pacific region is anticipated to register the highest CAGR over the forecast period.Market growth and competitive pressures for Biosimilars may vary from country to country, along with being a potential niche low-cost power in unregulated and semi-regulated markets, Indian companies are gearing to adopt guidelines more in line with the US or European Union (EU).As more and more Indian companies pass the approval processes including extensive clinical trials, India will soon emerge as a strong, relatively low cost supplier of Biosimilars products. Validation of biosimilars with reference biologics is a important aspect of the overall process of development. EMA and FDA which are the regulatory authorities actively regulate the commercialization and development of biosimilars. The first biosimilar was approved and marketed in India in 2000, U.S.A approved its first biosimilar in 2015 as per Generics and Biosimilars Initiative (GaBI), India thus has much more experience in manufacturing biosimilar and a regulatory environment better than other parts of the world. India has a thriving biosimilars market with 66 approved biosimilar products available, while Europe has 31 biosimilars on the market and the US has 5. India is emerging as an important player in the global biosimilar market.The key types of Biosimilars Market are developed markets and emerging markets. Examples of developed markets are the United States, EU5 and Japan. In emerging markets, the large pockets of nonconsumption and untapped demand characterized by poor physical and financial access to currently high priced biologics provide favorable long-term growth opportunities . Factors driving the global biosimilars market are availability of medicines at 25 to 40 percent lower prices than original branded products, expire of existing patents, rising prevalence of chronic diseases such as cancer and diabetes, higher probability of Return on Investment than with new product R&D.In 2012, India drafted the ‘Similar Biologics Guideline’ by the Central Drugs Standard Control Organisation (CDSCO) and the Department of Biotechnology. Biosimilars in India has already attracted large investments in areas of research, clinical trials and manufacturing. In future, Indian market will also see lot of strategic partnerships emerging between global and Indian companies to leverage each other’s potential. The Indian Biosimilars market provides numerous growth and investment opportunities for Indian and Foreign players In August 2016, CDSCO made some revisions to the country’s biosimilar guidelines. Biosimilar therapeutic products in India consist primarily of vaccine (Hepatitis B vaccine), monoclonal antibodies, recombinant proteins and diagnostics, insulin, erythropoietin, granulocyte colony stimulating factor, streptokinase, interferon alpha-2B, Rituxinab, epidermal growth factor receptor, chorionic gonadotropin and heparin. Indian pharma companies are now making significant investments into biosimilar development and production in an attempt to secure the early mover advantage and increasingly partnering with western counterparts to launch a greater number of biotherapeutics in both local and international markets.In 2013, Roche teamed up with Emcure Pharmaceuticals to manufacture Herceptin in India after its patent expire and sell at a reduced price in under a different name with the intent of maintaining its strong market share. Indian firms are using differing strategies to sustain in biosimilar market, i,e., some doing in house research while others are attempting to lower risk by taking the licensing route. A lot of companies have emerged in the production of biosimilars and have been changing the face of pharmaceutical market, in search of improved quality biosimilars some of them are Novartis, Celltrion Inc. , Amgen, Biogen, Merck & Co. ,Coherus BioSciences Inc etc. Tendency towards investing in biosimilars has increased around the world and India has a strong potential to emerge as a key player in the manufacture and marketing of biosimilars with its large consumer base. By 2030 new alterations in regulatory policies will increase affordability of the domestic market and allow growth at an accelerated pace and reach the target of $40 billion with 20% share in global market. In order to promote confidence in the new biosimilar products in India there is a need to develop well-designed clinical trial guideline to establish safety. Currently, for meeting the future challenges manufactures and regulators are strengthening up to improve cancer treatment access in low- and middle income group patients. Today the profitable products in biosimilars industries are monoclonal antibodies, G-CSF erythropoietin and peptide. Indian companies are increasingly partnering with international pharmaceutical giants in order to gain access to developed markets in the long-term, develop and market Biosimilars products. Inclination towards biosimilars has increased around the world. In 2010 Brazil developed biosimilars that led to formation of regulations in Latin America . International companies and international manufacturers are major drivers in expanding the biosimilars market. Approximately five biosimilar molecules in the development pipeline. Russia has been boosting its domestic pharmaceutical market which has lead to statistical increase in the domestic market share from 20% in 2012 to 50% by 2020, cooperative partnerships will be required for local manufacturers to increase the market value. Mexican government has established a market for biosimilars and its demand increased .
South korea has created a very highly advanced biosimilar market due to the support from the South Korean government. In 2012, part of national research and development budget was invested into biosimilars development. Twelve biosimilars have been approved and government has set goal for domestic bio pharmaceutical companies to win some percentage of the global biosimilars market in coming years . In South africa half of the market is made up of generics. Guidelines for biosimilars were set down in 2010, a lot of Indian companies begin to invade the South African biosimilars market and are trying to reduce the cost of drugs costs . Companies cost structure must be lower than what presently exists in the market without compromising with the quality and safety profiles of their biosimilars. In 2014, China issued draft biosimilars guidelines however a clear regulatory pathway for biosimilar is yet to be approved once its done the market will be very strong as it has volume potential and ability to pay. Factors that limit market growth of biosimilars are lack of regulatory guidelines,consumers brand preferences,reluctance of physicians to prescribe biosimilars,the high capital required for research and development. Although it is generally expected that biosimilars will emerge as a rapidly growing segment of the biopharmaceutical industry, their uptake faces several challenges . Despite their promise, biosimilars face competition from non-original biologics and bio-betters: Regulatory uncertainty, Production complexity, The regulatory policies governing biosimilars are still in flux, with major markets like China lacking consistent and clear pathways. The United States issued draft biosimilars guidance in 2013, and although the FDA recently approved the filgrastim biosimilar, the agency has yet to finalize a formal approval pathway. Unlike generics, the cost, time, and risk of biologics production are higher, and these are typically passed on to the consumer in terms of higher prices. While generics cost between $1 million and $5 million to develop, biosimilars cost between $100 million and $200 million.vii Biosimilars are more complex to develop and manufacture due to the inherent variability between one living cell and another, and the inability to exactly replicate the manufacturing or structure of the originator biologic. Interchangeability Competition The lack of clear guidelines on substitutability and interchangeability with reference biologics will likely cause physicians to exercise more caution in prescribing biosimilars until they gain comfort with the quality and efficacy of biosimilars. When the FDA reviewed Sandoz’s filgrastim, there was much speculation on whether interchangeability would be recommended. However, the FDA only focused on biosimilarity. This means that Sandoz may need to show comparative data and engage in market education to drive prescriptions and increase market share. Biosimilars face competition from at least two sources: biobetters from branded companies and brand consciousness from consumers. Biosimilars are anticipated to engage primarily in “brand-on-brand” competition with their reference therapies, unlike Hatch-Waxman generics. Also unlike generics, which are heavily discounted, biosimilar discounts can be offset by rebates and service agreements for branded biologics, thereby making biosimilars less attractive. With more sophisticated and long-term biologic treatments (e.g., monoclonal antibodies and growth hormones) and the associated treatment chronicity, it could take longer to demonstrate and convince stakeholders of the benefits of switching.While biosimilars growth potential appears bright, winning with biosimilars in emerging markets is not a simple undertaking. Companies seeking entry or expansion should craft a strategy to address the specific challenges in the emerging markets and incorporate the lessons learned from developed markets. A unique value proposition will likely be required to tap into the large populations in emerging markets who cannot access high-priced biologics. These companies should develop robust market-access strategies and should be prepared to make upfront investments to drive adoption, and shift business models from profit to volume. Upfront investments will likely require a strong emphasis on physician and patient education to address non-consumption, as well as supply chain investments to better enable access to the medication. Part of this education may come through the sales force, who should be fully equipped to meet the needs of the patient. Finally, manufacturers should work with local players to help navigate the knowledge of local market nuances and lean, low-cost manufacturing, coupled with the strong international brand and reputation of the manufacturer, will help to propel the growth of biosimilars in emerging markets.

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