Biosimilars 1 What are Biosimilars 2 Difference to

Biosimilars 1. What are Biosimilars 2. Difference to Generics 3. What can they do for us in the future 09. 2016 IHS

Biosimilars Biological Products Many of today’s important medications are biological products. Biological products are made from living organisms. The material they are made from can come from many sources, including humans, animals and microorganisms such as bacteria or yeast. Biological products are manufactured through biotechnology, derived from natural sources or, in some cases, produced synthetically. Biological products are among the medications used to treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis and various forms of cancer. 09. 2016 IHS

Biosimilars Biological Products Most biological products are more complex in structure and have larger molecules or mixtures of molecules (however can consist of relatively small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies) than conventional drugs (e. g. Aspirin, also called small molecule drugs). Conventional drugs are made of pure chemical substances and their structures can be identified. Most biologics, however, are complex mixtures that are more difficult to identify or characterize and to manufacture. 09. 2016 IHS

Biosimilars Production facilities for Biologics / Biosimilars 09. 2016 IHS

Biosimilars What are biosimilar and interchangeable biological products? There are two new types of biological products: biosimilar and interchangeable. Biosimilars are a type of biological product that are licensed (approved) by FDA or another health authority (HA, e. g. EMA) because they are highly similar to an already FDA or another HA approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product. An interchangeable biological product, in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient. 09. 2016 IHS

Biosimilars Will biosimilars work in the same way as the biological reference product they were compared to? Yes, biosimilars have no clinically meaningful differences in terms of safety and effectiveness from the reference product they were compared to. In addition, a biosimilar needs to have the same mechanism of action as the reference product it was compared to, which means it will work in the same way as the reference product. The FDA or another HA will only approve a biosimilar product if it has the same mechanism of action, route of administration, dosage form, and strength as the reference product. Additionally, a biosimilar can only be approved for the indications and conditions of use that have been previously approved for the reference product. 09. 2016 IHS

Biosimilars Are biosimilars generic versions of biological products? No, generic drugs are copies of brand-name drugs, have the same active ingredient, and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. That means the brand-name and the generic are bioequivalent. Biosimilars are highly similar to the reference product they were compared to, but have allowable differences because they are made from living organisms. Biosimilars also have no clinically meaningful differences in terms of safety, purity, and potency from the reference product. 09. 2016 IHS

Biosimilars What are Generic Drugs? A generic drug is identical--or bioequivalent--to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. Generic drugs save consumers, hospitals and health insurance systems quite a lot of money. 09. 2016 IHS

Biosimilars WHY can they be cheaper? New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA or another HA to sell generic versions. The process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962 (US market). 09. 2016 IHS

Biosimilars Examples for Biosimilars Approved by FDA: Inflectra is biosimilar to Remicade (infliximab). It’s approved for multiple conditions, including: Crohn’s disease Ulcerative colitis Rheumatoid arthritis Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis 09. 2016 IHS

Biosimilars Examples for Biosimilars Zarxio (filgastrim-sndz) is biosimilar to Neupogen It‘s approved for multiple conditions, including: Cancer Hematopoietic Stem Cell Transplantation Neutropenia Erelzi is biosimilar to Enbrel (Etanercept) It‘s approved for multiple conditions, including: Autoimmune diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis (JIA), ankylosing spondylitis(AS) 09. 2016 IHS

Biosimilars Biologics versus Biosimilars Biologics are different from conventional medications. Conventional medications— drugs—are generally made from chemicals or chemically synthesized, and therefore their structure can be relatively easily defined. Unlike conventional medications, biologics can’t be made by following a chemical “recipe. ” Biologics come from living organisms that are variable in nature. Because of that, developing biologics is a far more complex process than manufacturing drugs. Currently, biologics are among the fastest growing segments of the prescription product market. Pharmaceutical Players have a great interest to enter this market with biosimilars, but 09. 2016 IHS

Biosimilars but…………… Obstructive role of state and bureaucracy and time involved in testing and licensing slow down new entrants to the market New entrants face additional commercial risk that they may be instantly undercut and even driven out of business by the incumbent slashing its own prices Private sector pharmaceutical companies with shareholders have a right and a responsibility to turn a profit Politicians and society at large object to profiteering of pharmaceutical companies and put public pressure when there are obvious excesses in pricing Some pharmaceutical companies decide not to take the risk under given circumstances 09. 2016 IHS

Biosimilars Increased Options, Lower Costs? Biosimilars are likely to create greater competition in the medical marketplace. This could not only increase treatment options for patients but also lead to less expensive alternatives to comparable products. With an increasing number of biosimilars on the market, consumers may expect to get equally safe and effective treatment, but at lower costs. 09. 2016 IHS

Biosimilars Thank you for your attention! Questions? 09. 2016 IHS