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Super Generic Innovation in Pharmaceutical Industry
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Super Generic Innovation in Pharmaceutical Industry

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The pharmaceutical market needs new alternatives, and for these new products, innovation or “re-innovation” isinevitable. In other words, generic companies need to ...

The pharmaceutical market needs new alternatives, and for these new products, innovation or “re-innovation” isinevitable. In other words, generic companies need to
implement new strategies and new business plans. The basic question is: How can this innovation take place in a so-called “copycat-maker” system?

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    Super Generic Innovation in Pharmaceutical Industry Super Generic Innovation in Pharmaceutical Industry Presentation Transcript

    • Want to talk about the latest industry issues? Join the discussion forum. September 2012 NPT | The Community of Big Thinkers packaging, and distribution systems, are all on the list of possible innovations offered by generic companies. Offering a safer, value-added product to the patient/ consumer is one of the pillars of the new business models. It is also a milestone for generic competition, sliding from price- based competition to product-quality competition with novel products. To date, little is known about innovation in the generic pharmaceutical industry, except for some research on the technical and pharmaceutical diversification of “super-generic” products by using life- cycle management. It is important to notice that this transformation brings changes not only to products and processes, but also to the actors, relationships, institutions and to knowledge itself. This opens the door for innovative development in the “super- generic” space differing from the original product in formulation, combination, or the method of delivery. Themanagementsystemineachcompany is driven by health policy, the healthcare system, pricing and reimbursement, the social and economic environment and the medical culture. Portfolio management in the pharmaceutical industry requires a combination of risk-taking and risk- hedging. Business model innovations are becoming increasingly important to foster competitive advantage, and thus they are decisive for a company’s long- term success. However, a widely-accepted and commonly understood definition of business model innovation is still missing. In this regard, patient/customer- centered business models are considered a successful strategic alternative. New customers have emerged bringing a better-informed generation of patients that are searching for cost-effective treatments and an aging population and emerging markets that are influencing the new business models. Innovative business models are tailored according to a new approach to risk, blue-ocean strategy, partnering for missing skills, marketing and sales forces. Emerging markets may be chosen based on their potential, risk evaluation, and strategic environment. The future of these markets depends on deep local insight and adaptation in a social and economic context. The innovation in product portfolios aims to satisfy unmet medical needs and provide patient compliance with high- quality treatments. Innovative product portfolios are scientifically within reach of generic producers, but the production of these products is based on the economic prospect of the industry. As for patenting the new products, the regulatory affairs and intellectual property rights in each country are a major milestone for the “super generic” and biosimilar manufacturers. To complement our qualitative approach, future research needs to carry out a quan- titative study about the determinants of innovation in the generic pharmaceutical industry, as well as the R&D compo- nents. It is also interesting to follow the changes throughout the entire pharma- ceutical industry to see what will be the impact of innovation on the generic in- dustry in regards to R&D in the original or big pharmaceutical companies. In this new industrial mapping, the generic pharmaceutical industry is taking an important place by bringing high- quality “super-generic” and value-added versions to the market. Using modern infrastructure can reduce the time of development to facilitate cost-savings in these companies. I nadditiontothecostadvantagesofgenericpharmaceuticals in healthcare systems, the importance of the generic pharmaceutical industry lies in the competitive dynamic it brings to the global market. In general, the competition is focused on price and product quality/diversification. The low price of generics products threatens to undermine the sustainability of the generic pharmaceutical industry in regards to its low margins, impressive number of competitors, increased requirements for pharmacovigilance on generic manufacturers, the mature markets in developed countries, and the post-patent cliff arena after 2015. The time of generic companies focusing exclusively on the development of commodity generics is over. The pharmaceutical market needs new alternatives, and for these new products, innovation or “re-innovation” is inevitable. In other words, generic companies need to implement new strategies and new business plans. The basic question is: How can this innovation take place in a so-called “copycat-maker” system? Due to the innovation slump in the original pharmaceutical industry, the generic industry itself is aiming to become an engine of innovation. The distinction between innovative and generic activity has become blurred in the last few years. The generic pharmaceutical industry is now re- innovating by acquiring strategic changes in their management/business models and by creating new product portfolios fortified with “super generics”, new chemical entities and novel drug delivery systems. To illustrate the scope of the generic pharmaceutical industry for innovation, several generic companies have patented their new products, both in terms of drug substance (process patents and polymorph patents) and formulations. The quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. The success of these companies has illustrated the possibility of changing the classic models of “copy-maker” by moving towards new value-added products, new manufacturing strategies and new business models. Innovation is an economic strategy to capture more patients and consumers by increasing the quality and efficiency of a product and by decreasing the risks, side effects and toxicity. Innovation thus satisfies the unmet needs of a better-informed generation of patients and pharmacists. The reduced dosage, along with new formulations, combinations, drug-delivery systems, The assessment of innovation in the generic pharmaceutical industry: a qualitative review Super Generic Innovation SUPER GENERIC INNOVATION - GENERICSGENERICS “Innovation is an economic strategy to capture more patients and consumers by increasing the quality and efficiency of a product and by decreasing the risks, side effects and toxicity. “ by Fereshteh Barei, Paris Dauphine University Fereshteh Barei is a PhD candidate at LEGOS laboratory for Health economics and Management, at Dauphine University in Paris. Her research program is focused on Innovation strategy, the generic pharmaceutical industry evolution and Super generic product status in international pharmaceutical market. She has worked in the health programs at the French Foundation in Paris and pharmaceutical market studies in Sanofi-Aventis, GERDES association focused on health care related publications, before heading for this thesis project.