11^th European Biosimilars Congress April 26-27, 2018 Rome, Italy

Biosimilars Market is experiencing a growth at an exponential rate. Presently around 700 biologics are making progress in the research pipelines of nearly 250 biopharma companies. Biosimilar insulins have already started revolutionizing the future drug development in the realm of diabetology. Biosimilars of Adalimumab, Etanercept, Rituximab, Peg-Filgrastim, Trastuzumab are expected to hit the market soon. Biosimilar of Humatrope, biosimilar of Eprex, biosimilar of Neupogen, biosimilar of Remicade have already been enjoying a greater market share in Europe than the reference product itself.. 

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%.

Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchangeability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of biologics and biosimilar products.

On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry.

Competitions and/or success in the present pharma industry is determined by the winning patent strategy which mostly pertain to the generic market entry. Generic and branded drug manufacturers both the patent strategy proximally belongs to the Hatch-Waxman Act statutory scheme and ANDA litigations. The Hatch-Waxman Act enacted in 1984 with amendment in 2003 facilitated the entry of generics at an early stage-thereby finishing the battle of branded generic ANDA of blockbuster drugs. All the same the Biologics Price Competition and Innovation (BPCI) Act has maximized the branded-generic patent duel in the biologics realm by imposing a litigated framework on follow-on-biologics. On September 16, 2011 President Obama signed the American Invents Act(AIA) of 2011 indicating a further strategy evolution of patenting branded and generics.

An FDA analysis of drug prices from 1999 to 2004 found that the discount from generic competition was just 6% with one generic competitor, but jumps to 48% with two generic competitors, 56% with three, 61% with four and 67% with five generic producers in a market. Within 2 years of the expiration of the patent of the popular drug Zantac in 1997, generics of Zantac accounted 90% of the treatment’s total sales, and the price for patients was about 10% of its pre-generic price. European patents on biologic treatments began to expire in 2000, and in April 2006, Sandoz and Biopartners successfully received EMEA approval for the first European biogenerics, two products containing human growth hormone.

Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved "innovative" versions of original  products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session also finds place for all the biosimilar exhibitiors associated with the field of biosimilar and biologics.

2014 was a banner year for orphan drugs, which are drugs that treat "rare" diseases/disorders affecting fewer than 200,000 people in the U.S. A total of 41 new molecular entities (NMEs) and biologics (BLAs) were approved by the FDA in 2014 - 15 of those were approved in December alone (11 in final two weeks.)

This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Clinical biosimilar tracks.docx PK/PD studies, Toxicological studies and Aspects of genotoxicity tests.Clinical trials are designed in stages I-IV so as to receive a clear picture of the drug candidate in respect to its pharmacokinetics and pharmacodynamics parameters.

Research estimates that there are 280 Biosimilars in the pipeline, and clinical trials are increasing by 20% per year.Biologics also represent over 40 percent of the drugs in each of the preclinical, Phase I, Phase II, and Phase III trial stages.

With Europe that paved way to the uptake of biosimilars over a decade ago, the consequences of Brexit would be potentially harder on UK. Presently UK is no more bound to follow the guidelines of EMA. Also research grants from Innovative Medicines Initiative and Horizon 2020 would no more be available to UK. All the same, EMA has its headquarters in London, UK. The thus arising complications would definitely have certain consequences on the Biosimilars scenario in UK and EU.

This track discuses about the generic drugs impact on global biosimilar market , Cost and risk management, Adopting innovative mechanisms such as risk-sharing arrangement, European market for biosimilars.

A growing global market for biosimilars is gaining momentum in response to the expiration of patents for a number of key biologics and consumer demand to reduce treatment costs. Thus, according to Research and Markets, the global biosimilar market, valued at $2 billion in 2012 is projected to reach $19.4 billion by 2018.

Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved "innovative" versions of original  products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session also finds place for all the biosimilar exhibitiors associated with the field of biosimilar and biologics.

Biosimilar iinovative products are on the rise. The number of new drugs seeking approvals are growing at a compounded rate of around 5% half early. Almost 1.5 times the number of biomilars are expected to be in the market in 2016 compared to in the last 5 years.

The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugs. Biopharmaceutics Classification System and invitro and invivo classification discusses about ADME pathways of different drugs. This also includes BCS biowaivers, In vitro diffusion cells for dissolution testing in formulation development, In vitro preclinical ADME/BCS testing.

Until in vitro in vivo correlation achieves the required degree, the biosimilar drug will not be able to meet the needs of the original drug candidate. Hence the proportion of BCS and IVIVC based biowaivers are fairly low ~0.5-1% of total pharmaceutical products.

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. 

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.

Biologic Drugs, or biologic response modifiers, are medications genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. Biologics target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. Biologic response modifiers (biologics for short) are drugs that are genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. They target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. The proteins targeted include tumor necrosis factor (TNF), interleukin-1 (IL-1) and interleukin-6 (IL-6), which are involved in joint inflammation. Biologics are typically reserved for people whose arthritis has not responded well to disease-modifying antirheumatic drugs (DMARDs).

Biological Medicine works with the biology of the body and its natural healing capabilities as well as the spiritual, emotional and physical aspects of disease. Dis-ease means that the body’s regulation is not working properly and needs to be brought back into its natural dynamic state where the immune system is in full regulation.  It therefore looks for root causes for the presenting symptoms of disease- the underlying factors causing a person to present with a certain illness.  These root causes may consist of several factors which have built up over time and can include; diet, food allergies, intestinal disturbances, family history, stress, environmental factors, heavy metals, dental problems, hyperacidity, trauma, exposure to bacteria or viruses or electromagnetic disturbances.

A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. At that time the Biowaiver was only considered for scale-up and post approval changes (SUPAC) to pharmaceutical products.

The term biobetter refers to a recombinant protein drug that is in the same class as an existing biopharmaceutical but is not identical; it is improved over the original. Biobetters build on the success of existing, approved biologics but are considered less of a commercial risk than developing a brand new class of biologic. Biobetters are not entirely new drugs and they aren't generic versions of drugs, either. While many consider biosimilars to be generic versions of biotech drugs, it isn't possible to create a generic biologic drug. That's because biopharmaceuticals are produced in living organisms - such as animals or bacteria - and cannot be copied exactly.

Entrepreneurs who are willing to put in hard work and invest in the field of biologics and biosimilars will find this meeting the best place to properly shape their drive for the new endeavours. Also this meeting will help them find the best experts who can make their investment fruitful and worthwhile.

Biologics are the Future of Medicine and by 2016 it is predicted that eight of the top 10 products on the market will be biologics. The Price of Brand Biologics Continues to Increase  and U.S. average annual spending growth from 2002 to 2007 was 16% for biologics, compared with 3.7% for drugs.The average daily cost of a brand name biologic product is approximately 22 times greater than a traditional drug. Biologics can cost as much as $10,000 to several hundred thousand dollars per year.