What are Supergenerics
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The document discusses supergenerics, which are generic drugs that offer improved features over existing generics. Supergenerics can provide a lower-risk alternative to developing new drugs and offer shorter development timelines compared to new chemical entities. The 505(b)(2) regulatory pathway allows supergenerics to incorporate existing clinical data, reducing development costs versus the traditional 505(b)(1) new drug application process. Supergenerics aim to create value through improved formulations, delivery methods, or other enhancements compared to existing generics while maintaining a known safety profile. This offers the potential for temporary market exclusivity and competitive advantages for generic drug companies.
What are Supergenerics
- 1. BY DR ANTHONY MELVIN CRASTO W O R L D D R U G T R A C K E R I N D I A A U G 2 0 1 6 WHAT ARE SUPERGENERICS
- 2. This is a vast topic and a short overview is given and in no way complete justice can be done for this
- 3. The Long Road to a New Medicine Discovery Exploratory Development Full Development Registration Large Amounts of Candidate Medicine Synthesized Project Team and Plans Synthesis of Compounds Early Safety Studies Candidate Formulations Developed Extensive Safety Studies Screening Studies in Healthy Volunteers Phase I Candidate Medicine Tested in 3-10,000 Patients (Phase III) Studies in 100-300 Patients (Phase II) Clinical Data Analysis
- 5. NDA 505(b)(2) Applicability 21 CFR 314.54 Contains Reports of Safety and Effectiveness wherein some investigations are not conducted by applicant and for which the applicant has no right of reference Types of products 21 CFR 314.54 New Chemical or New Molecular Entity Info from studies not conducted by applicant Info where applicant lacks the right of reference Changes to Previously Approved Drugs (RLD) New Dosage Form, Strength, Route of Administration Substitution of an Active Ingredient in Combo Product Formulation changes outside 505(j) limits
- 8. 8 World Economy : The Paradigm Shift Agri.Economy Industrial Economy Knowledge Economy Land Labour Capital Machinery Management Innovation Appliedresearch Science & Technology IPR
- 10. Supergenerics may be able to offer a low-risk, low-cost alternative to the traditional pharmaceutical development of new medicines, due to their shorter development timeline. New Chemical Entities (NCEs) take a long time to develop, often at a cost of over $1billion. Conversely, the development of a supergeneric is more comparable to that of a generic compound, as it has a known mechanism of action and an established safety and efficacy profile.
- 11. The supergeneric approval pathway also offers products a less complex clinical development process. Paper NDA or 505(b)(2) is the drug development pathway that companies are required to file under in the US for the development of novel formulations and new combinations, such as supergeneric products. Importantly, this route allows companies to incorporate pre-existing data, including late-phase clinical data, into its NDA by reference, which can lead to substantial savings in comparison to pursuing a NDA 505(b)(1). In addition, temporary market exclusivity is guaranteed in the US, as the NDA 505(b)(2) pathway attracts a three- year period of market exclusivity, providing some degree of product protection
- 13. The generic market is more competitive & the pharmaceutical market players are looking for developing newer versions of generics by adding value to the product and getting the extension in market exclusivity for the particular brand. As new drug therapies are reaching the market after a long term of regulatory battle & high investment on research for which the companies are getting only 20 years of monopoly (patent), the markets have been in search for innovations in the generic products which can extend the patents & also offer extension in market exclusivity. These super generic drugs are not only better in patient compliance, but also provide better therapeutic effect than the other already existing generic versions. The market leaders follow the quality by design approach, multifunctional excipient, modifying dosage form & reforming the release pattern to develop the value added therapies which create a new segment and uplift the growth in generic market and even assure better quality & economic viability. This article highlights the global generic segment, market growth and opportunities for innovation in the generic market to develop super generic versions, development & commercialization strategies of super generics with due examples of marketed products of super generics.
- 14. New chemical entity (NCE) / branded drugs New chemical entities are the innovative drug molecules of the innovators for which they have to submit the new drug application (NDA) with both non clinical and clinical data and get the exclusivity / patent for 20 years.
- 15. Generic drugs These are off patent version of branded drugs that are identical & bioequivalent to the innovated drugs in terms of the dosage form, strength, route of administration and therapeutic effects. For the approval of marketing of generic versions of brands the companies have to file the abbreviated new drug application (ANDA) and just have to submit data related to the bioequivalent studies.
- 16. Super generics / improved therapeutic entity Super Generics are recent generic product categories that are differentiated by improved pharmacokinetics, delivery, patient convenience /or an improved manufacturing process and with better therapeutic effects from me to generic products. For approval of marketing of Super generics companies have to file the new drug application (NDA).
- 17. 17 Hatch-Waxman Basics Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman”): Patent term restoration (partial) to compensate innovators for pre- market approval regulatory delay Process to approve duplicates of approved drugs that rely on safety and efficacy studies by innovator Complex scheme of patent information and patent certifications Regulatory exclusivities for new chemical entities, new clinical investigations and first ANDA patent challenger
- 18. 18 Drug Application Types A New Drug Application (NDA) contains full reports of safety and efficacy studies conducted by or for applicant or as to which it has right of reference An Abbreviated New Drug Application (ANDA) is for a generic duplicate of an approved NDA product: Borrows safety and efficacy studies from NDA Must have identical active ingredient, route of administration, dosage form, strength, labeling and intended use Must demonstrate bioequivalence
- 19. 19 Drug Application Types A “505(b)(2)” application is an NDA for a modification to an approved drug (e.g., different active ingredient, dosage form, strength, etc.) relies upon one or more studies not conducted by or for applicant and for which applicant has no right of reference (e.g., published studies or FDA finding of safety/efficacy of approved drug) application must contain sufficient data to support the safety/efficacy of the modification A Biologics License Application (“BLA”) is an application to market a biological product (NB. some biologics are approved by NDA route)
- 20. 20 505(b)(2) NDAs An end run around statutory “sameness” concept for borrowing safety and efficacy? Citizen’s Petitions filed by Pfizer challenging FDA’s use of 505(b)(2) NDAs: Only ANDAs should be allowed to borrow innovator’s safety and efficacy data Dr. Reddy’s should not be allowed to file 505(b)(2) application for a different salt of Norvasc and borrow Pfizer’s proprietary data (Pfizer’s NDA contained data for both salts) Oct. 2003 FDA responded that it may reconsider use of 505(b)(2) for different form of active, but then approved Dr. Reddy’s salt variation anyway Pfizer sued FDA (before CAFC decision granting Pfizer PTE for Dr. Reddy’s salt variation)
- 21. 21 New Clinical Investigations Exclusivity Eligibility: NDA (including 505(b)(2)) or supplemental NDA that contains: reports of “new clinical investigations” (other than bioavailability studies) that are “essential to the approval” and are “conducted or sponsored by the applicant” Period: 3-year period of exclusivity from approval of NDA or supplemental NDA Bars: Approval of ANDA or 505(b)(2) application (not NDA) for same conditions of approval of the drug for which exclusivity was granted
- 41. Recap
- 43. The potential of supergenerics development is to create a simplest or advanced drug delivery system rather than to create a complex drug molecule. The various challenges that company may face while developing the supergenerics, but supergenerics are capable to create a global market. The implementation of QbD paradigm is useful for developing the supergenerics. Supergenerics is comes as opportunity on door for Indian generic companies. Supergenerics also have a market in personalized medicines. The supergeneric is an economic strategy for counteracting the saturation of pharma industry.
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- 48. SUCCESS FORMULA