8^th Asian Biologics and Biosimilars Congress August 10-12, 2017 Beijing, China

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. The act provides some protection for drug innovators while facilitating and providing incentives for companies to file ANDAs.

Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. FDA requires licensed biosimilar and interchangeable biological products to meet the Agency’s rigorous standards of safety and efficacy.  That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. This track includes:

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. 

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.

Biologic products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems. The licensing of these products, however, relies on the experience gained with the original biopharmaceuticals.

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. 

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.

The global biosimilars market alone  is expected to reach $6.22 Billion by 2020  from  $2.29 Billion in  2015, at a  compound annual growth rate (CAGR) of 22.1% from 2015 to 2020. Geographically, the global biosimilars market is dominated by Europe, followed by Asia-Pacific, Rest of the World (RoW), and North America. However, the Asia-Pacific region is likely to witness the highest growth rate during the forecast period.

There are thought to be more biosimilar products currently in development across the Asia-Pacific region than anywhere else in the world, leading to wealth of opportunities for investigators and patients interested in taking part in biosimilar clinical trials. India, Japan, South Korea, and China are particularly active in biosimilar research efforts. 

Biologics are complex, protein-based drugs including insulin, monoclonal antibodies to block inflammation in rheumatoid arthritis, and a range of drugs to treat cancer, multiple sclerosis, and other serious diseases. While biologics have revolutionized treatment for many conditions, they are often expensive in terms of cost per dose. The introduction of biosimilars is expected to reduce prices, albeit to a lesser degree, comparable to small-molecule generics.

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.

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. 

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%.

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.

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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