12^th Asian Biologics and Biosimilars Congress August 20-21, 2018 Tokyo, Japan

The biosimilars market is set to expand over the next decade and beyond as a result of two major factors: the impending patent expires on blockbuster biologics and the financial crisis that is driving payers to push for wider adoption of biosimilars to manage the escalating costs of healthcare. Although many companies are keen on getting a share in the biosimilars market given its promising outlook, bringing these complex molecules from bench to launch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved. 

The global biosimilars market is growing at an exponential rate. The CAGR from 2015 to 2020 is projected at over 22%. The biosimilars market is expected to be around $6.2 billion by 2020 from only $2.3 billion in 2015. By the end of this decade the biosimilars would surely occupy 27% of the total pharmaceutical market. Moreover, with the global rise in concern for more accessible-improved- cost effective healthcare, biosimilar drugs would be a more apt choice to the payers, end users, manufacturers over the costly reference biologics. Originator biologics are as costly as about $100,000 per year per patient. Biosimilars on the contrary can be offered at a 30-40% lower price than that of the reference product. However, with all the success stories and opportunities there also lies a sobering 50% failure rate in developing and obtaining license towards marketing of biosimilars.  The biosimilars market is categorized into mainly four zones – North America(USA and Canada); Europe(UK, Germany, Spain, Italy, France and Rest of Europe); Aisa-Pacific( China, India, Japan, South Korea) and rest of the world ( LATAM and MENA). Key players of the biosimilars market include Amgen, Hospira, Teva, Sandoz International GmbH, Dr. Reddy’s Laboratory, Biocon, Roche, Celltrion, Catalent, Mylan and Merck. There are also certain other companies which are gaining importance in biosimilar de​velopment like LeanBio Pro-Spain, PPD-USA, SGS Life Sciences-UK, Therapeutic Proteins International-USA. The biosimilars development is mainly concentrated in the therapeutic domains of oncology, blood disorders, autoimmune disorders, endocrine disorders and infectious diseases. 

Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) are sufficient to demonstrate safety, purity, and potency in one or more.

As clinical trial data are usually insufficient to identify rare adverse effects, the general pharmacovigilance requirements applied to biosimilars are the same as those for any biological medicine. 

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. Biosimilar innovative products are on the rise. The numbers of new drugs seeking approval are growing at a compounded rate of around 5% half early. Almost 1.5 times the number of biosimilars are expected to be in the market in 2017 compared to in the last 5 years.

Global uptake of Biosimilars has led to the adoption of distinct legal and regulatory frameworks in different countries. Thorough understanding of the marketing strategies, newer analytical characterization techniques and proper communication between regulatory authorities and manufacturers may help to bring a biosimilars more easily in the global market.

South Korea was the first country worldwide to approve biosimilar versions of etanercept according to international standards. Australia is the world’s first highly regulated market to allow pharmacy level substitution of a monoclonal antibody biosimilar for an originator. As of April 2016; 8 biosimilars have been approved in Japan, including the recent approved insulin glargine biosimilar. A recent report has shown that biosimilars in India have witnessed nearly 20% annual growth for the last financial year and now make up for about 2.5% of the overall biologics market.

Manufacturing processes for biosimilars stand on their own and need not duplicate the originator’s production methods. Instead, the focus is on extended characterization efforts to show that the biosimilar is ‘highly similar’ to the reference medicine. That can really cut clinical efforts and save developers a lot of money. There are also opportunities for greater process economy through improved production technology as, for example, through the implementation of single-use equipment, more rigorous process monitoring, process intensification, and other improvements.

Emerging trends suggest that Asia is attracting major investors interested in biosimilars industry; the growth prospects are driven by streamlining of regulatory guidelines and high adoption rate for biosimilars among physicians, payers and patients.

In innovative drug development, three phases, and usually multiple studies per phase, of clinical research are required. In contrast, biosimilar clinical development can be abbreviated because of the breadth of understanding of the reference biologic and if the structural or functional similarity of the biosimilar has been preliminarily demonstrated analytically.  While clinical requirements differ by regulatory agency, in general, two phases of clinical studies are required – a Phase I study to demonstrate similar pharmacokinetics (how a medicine moves through the body) and a Phase II study of pharmacodynamics (effect of the medicine in the body), along with a pivotal study, referred to as Phase III, to demonstrate similar efficacy, safety and immunogenicity to the reference biologic.

A biosimilar medicine is developed to be highly similar to a biological medicine that is already approved and available for patients, once the original patent has expired.

It is predicted that as patents expire over the next five years for a number of biological medicines with high sales, the development of biosimilar medicines for the treatment of cancer, diabetes, rheumatoid arthritis and multiple sclerosis will be seen. It is also predicted that the monoclonal antibodies (mABs) will comprise a large proportion of the biosimilars market along with biosimilar insulins, which are also expected to enter the insulin landscape in the coming years as the patents for major insulin products begin to expire. The proportion of different biosimilars that reached market are Low Molecular Weight Heparins 44%, Epoetins 19%, HGH 11%, G-CSFs 7%, Interferons 6%, Insulins 5%, Others 8%.

Analysis of Biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. The development pathway of a biosimilar is unlike that of a novel biotherapeutic, requiring earlier extensive analytical characterization. Analysis of biosimilar and biologics takes the longest stretch towards establishing the product in comparison with the original product.

Any manufacturer seeking to develop and market a biopharmaceutical product requires comprehensive physicochemical structural characterization of the (glyco) protein. For biosimilar products, this task is magnified and forms the basis for further comparability. 

The legal issues pertaining to the the follow-on-biologics and biosimilars are one of the most aspects that requires an open discussion. Before the actual advent of biosimilars to the market legal issues have risen in numbers in their developmental stages. Renowned organizations have filed cases against each other two claim their rights and for other legal allegations related to the products. This track is dedicated to discussion of all such cases which has been argued in the court of law.

By 2002, the FDA had approved 36 new biologics, followed by 37 more in 2003, another 40 in 2004 and 39 more in 2005. By 2006, the leading category of biologic treatment, the red blood cell enhancer recombinant erythropoietin (EPO), generated $14 billion in sales revenues, or 40 percent more than the best-selling traditional pharmaceutical, Lipitor. More than 300 therapeutic antibodies currently are in clinical development and trials, compared to just 13 that already are widely available due to legal issues.

The Brexit effect on Biosimilars tends to be negative. Not only would it be a major setback towards approval and launch of biosimilars to the market but also it would be hindrance towards the cost cutting approach taken up by NHS.With Britain being among principal clinical trial centers is owned to see a decrease in the willingness of the manufacturers and researchers to carry out any further trials in Britain. Also Brexit will cause the principal motive of Bristish Biosimilars Association(BBA) to fall back- which aimed at increasing the use of biosimilars.

In the era of swelling costs of drug development and shrinking budgets, the pharmaceutical industry has been striving hard to find ways for saving precious resources. Tools evolved through naive scientific probing, like BCS (Biopharmaceutics Classification System) and IVIVC (invitro and invivo classification) can act as the magic-wands in such cases. Besides obtaining biowaivers, IVIVC has been applied in drug delivery during various stages of development, like formulation screening, setting dissolution specifications and product development. Nonetheless, the most critical pharmaco-economic application is the biowaiver by avoidance of expensive clinical trials. Newer paradigms like in vitro/in vivo relationship (IVIVR) are also being deliberated and practiced at industrial level, esp. for IR formulations.

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