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Biosimilar Patents

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The increasing demand from government agencies, insurers and patients to reduce the steep cost of blockbuster biopharmaceutical products has created considerable opportunities in the global biosimilar ...

The increasing demand from government agencies, insurers and patients to reduce the steep cost of blockbuster biopharmaceutical products has created considerable opportunities in the global biosimilar market. By the end of this decade, a significant number of blockbuster drugs will go off patent, allowing a large number of biosimilar products to enter the market. Regulatory developments favoring the biosimilar market in countries such as the US are expected to boost the profits and market share of the companies involved.
This presentation is compiled from freely available resources like the websites of FDA, EMA, WHO. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.

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Biosimilar Patents Biosimilar Patents Presentation Transcript

  • This presentation is compiled by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 1/23/2014 1
  • This presentation is compiled from freely available resources like the websites of FDA, EMA, WHO.  “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.  Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.  Drug Regulations : Online Resource for Latest Information 1/23/2014 2
  •  Significant demand to reduce steep cost of Biopharmaceuticals ◦ Government agencies, ◦ insurers and patients  Significant opportunities in the global biosimilars market.  Significant number of blockbuster drugs will go off patent  Regulatory developments favour biosimilars Drug Regulations : Online Resource for Latest Information 1/23/2014 3
  • WHO FDA EMA Japan Canada Similar Biotherapeutic Product Follow-on Biologic Biosimilar Follow-on Biologic Subsequent Entry Biologic A product highly similar to the reference product without clinically meaningful differences in safety, purity and potency. A new biological medicinal product claimed to be “similar” to a reference medicinal product, which has been granted a marketing authorization in the Community on the basis of a complete dossier in accordance with the provisions of Article 8 of Directive 2001/83. A biotechnological product that is produced by a subsequent-entry manufacturer and claimed to be comparable to a biopharmaceutical product already approved in Japan. A biologic drug that enters the market subsequent to a version previously authorized in Canada and with demonstrated similarity to a reference biologic drug. A biotherapeutic product similar to an already licensed reference biotherapeutic product in terms of quality, safety and efficacy. 1/23/2014 4
  • WHO FDA EMA Japan Canada • Case-by-case approach for different classes of products • Pharmacovigilance is emphasized • Generic approach is not applicable • Biosimilar should be similar to the reference in terms of safety, efficacy and quality • Step-wise comparability approach: comparison of the similar biotherapeutic product to reference biotherapeutic product in terms of quality is a requirement for decrease of non-clinical and clinical data required for approval 1/23/2014 5
  •  Most advanced of any region.  Legislation introduced in 2003  General guidances ◦ First in 2005 ◦ Two in 2006 outlining quality, clinical and nonclinical requirements. ◦ Three additional guidances are in draft. Drug Regulations : Online Resource for Latest Information 1/23/2014 6
  •  Guideline on Similar Biological Medicinal Products  GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS  GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: NON- CLINICAL AND CLINICAL ISSUES  Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)  GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES Drug Regulations : Online Resource for Latest Information 1/23/2014 7
  •  Additional guidances apply to six categories of products ◦ Therapeutic proteins, ◦ Vaccines, ◦ Blood-derived products, ◦ Monoclonal antibodies and ◦ Gene and cell therapies. ◦ Further, in 2011 a concept paper was issued on revision of the guidance, suggesting the process should focus on similarity rather than clinical benefit. ( EMA ) Drug Regulations : Online Resource for Latest Information 1/23/2014 8
  •  Generally follows the EU approach of showing similarity based on quality, safety and efficacy of biosimilar products.  A guideline on the quality, safety and efficacy of biosimilar products (Guidelines)  Slightly less inclusive scope than the EU guidance.  Guideline covers specific product categories ◦ Recombinant vaccines, ◦ PEGylated recombinant proteins and ◦ Non-recombinant proteins ◦ Excludes others (e.g., polyglycans and synthetic peptides). Drug Regulations : Online Resource for Latest Information 1/23/2014 9
  •  WHO  Health Canada  Singapore  India  Korea  Malaysia Drug Regulations : Online Resource for Latest Information 1/23/2014 10
  •  Federal Food Drug and Cosmetic Act („FFDCA‟) ◦ Abbreviated New Drug Application („ANDA‟) process in section 505(j) ◦ was established through the 1984 Hatch-Waxman Amendments to the FFDCA. ◦ Sets out a regulatory and dispute resolution framework for small molecule generics. Drug Regulations : Online Resource for Latest Information 1/23/2014 11
  •  Public Health Services Act („PHSA‟) ◦ Biologics Price Competition and Innovation Act („BPCIA‟) amends PHSA ◦ Was passed as part of the Affordable Care Act („ACA‟) ◦ President Obama signed into law on 23rd March 2010. ◦ US Supreme Court affirmed the constitutionality of the ACA and, thus, the BPCIA. Drug Regulations : Online Resource for Latest Information 1/23/2014 12
  •  Public Health Services Act („PHSA‟) ◦ BPCIA  For follow-on biologics or Biosimilars  Sets out a regulatory framework  Dispute resolution framework  Inspired by Hatch- Waxman Act Drug Regulations : Online Resource for Latest Information 1/23/2014 13
  •  Public Health Services Act („PHSA‟) ◦ BPCIA  For follow-on biologics or Biosimilars  Sets out a regulatory framework  Dispute resolution framework  Inspired by Hatch- Waxman Act Drug Regulations : Online Resource for Latest Information 1/23/2014 14
  •  Biosimilar development requires significant up-front time and investment  Average cost estimated to be between US$100m and $200m*  Average cost of bringing small-molecule generic is estimated to be between US $1m AND $5m  Two categories of follow-on biologics: ◦ Biosimilars ◦ Interchangeable‟ biologic products Drug Regulations : Online Resource for Latest Information 1/23/2014 15
  •  General application requirements ◦ Biosimilar to reference product ◦ Same mechanism of action as reference product ◦ Share the previously approved condition(s) of use ◦ Employ the same route of administration, strength and dosage from as reference product ◦ Have facilities that meet standards designed to ensure the biosimilar is „safe, pure and potent Drug Regulations : Online Resource for Latest Information 1/23/2014 16
  •  “Highly similar” to reference product ◦ Notwithstanding minor differences in clinically inactive components  How close does the proposed follow-on biologic compare to the reference product?  Application must demonstrate required biosimilarity through: ◦ Analytical studies ◦ Animal studies ◦ A human clinical study or studies that are sufficient to demonstrate the followon biologic is „safe, pure and potent‟  Scientifically difficult to prove equivalence between a follow-on biologic and a reference product. Drug Regulations : Online Resource for Latest Information 1/23/2014 17
  •  Chemical drugs ◦ Small molecules ◦ Easy to demonstrate equivalence of chemical composition  Biopharmaceutical drugs ◦ Larger in size and ◦ Complex in structure ◦ Current technology will not allow complete characterization of biological products ◦ Additional clinical trials may be necessary before FDA would approve a follow-on biologic Drug Regulations : Online Resource for Latest Information 1/23/2014 18
  • Structural and Functional Characterisation Human Pharmacokinetics & Pharmacodynamics (PK/PD) Clinical Knowledge e.g. Post-Market Experience Biosimilar Clinical Immunogenicity Animal Studies Highly Similar Clinical studies 1/23/2014 19
  •  FDA scientists will ◦ Evaluate the applicant‟s integration of various types of information ◦ Provide advice on scope and extent of development plan and, ultimately ◦ Provide an overall assessment that a biological product is (or is not) biosimilar to an approved reference product. Drug Regulations : Online Resource for Latest Information 1/23/2014 20
  •  Follow-on biologic may be substituted for the reference product without the intervention of the healthcare provider who prescribed the medication Drug Regulations : Online Resource for Latest Information 1/23/2014 21
  •  Application must show that ◦ The follow-on biologic can be expected to produce the same clinical results as the reference product in any given patient and ◦ If administered more than once, the „risk in terms of safety or diminished efficacy of alternating or switching‟ between the products is „not greater than the risk of using the reference product without such alternation or switch. Drug Regulations : Online Resource for Latest Information 1/23/2014 22
  •  The first biosimilar applicant ◦ A period of exclusivity during which no other product can be deemed interchangeable with the reference product. Drug Regulations : Online Resource for Latest Information 1/23/2014 23
  •  Period of exclusivity ends on the earliest of: ◦ One year after first commercial marketing ◦ If no expedited patent litigation suit is brought against that applicant under the PHSA § 351(l), 18 months after approval; ◦ If an expedited patent litigation suit is brought against that applicant under PHSA § 351(l), 18 months after final decision on all patents-insuit (or dismissal); or ◦ If an expedited patent litigation is brought against that applicant under PHSA § 351(l) and still pending, 42 months after approval. Drug Regulations : Online Resource for Latest Information 1/23/2014 24
  •  No application can be filed until 4 years after the date the reference product was first licensed.  No application can be approved until 12 years after the date the reference product was first licensed.  Paediatric exclusivity: can extend 4 and 12 year periods for 6 months each. Drug Regulations : Online Resource for Latest Information 1/23/2014 25
  • Patent Protection : 20 years from filling Patent filled Patent issued Data Exclusivity Approval of Reference Product Biosimilar application may be filled : 4 yrs or 4yrs+ 6m Patent expires Biosimilar application may be effective : 12 yrs or 12 yrs+ 6m Drug Regulations : Online Resource for Latest Information 1/23/2014 26
  •  BPCIA‟s approach is distinct from Hatch-Waxman Act: ◦ There is no requirement to list in the Orange Book patents the reference product sponsor believes would be infringed if a generic drug were marketed before expiration of the patents. ◦ There is no requirement for the FDA to suspend consideration of the generic drug application in question for 30 months or until the patent in question is found to be invalid or not infringed. Drug Regulations : Online Resource for Latest Information 1/23/2014 27
  • Biosimilar applicant (BA)submits application to FDA FDA notifies BA whether application has been accepted for review BA provides reference product (RP) sponsor confidential access to biosimilar application & information describing manufacturing Within 20 days after notification Within 60 days after receipt RP sponsor provides BA list of patents for which it believes it or patent owner that has granted it exclusive license could easily assert a claim of patent infringement and patents it would license. Within 60 days after receipt BA may provide a RP sponsor a list of patents and shall provide a statement on each patent on both list, why such patent is invalid , or that BA will not market until such patent expires, and a response regarding licensing. 1/23/2014 28
  • RP sponsor provides BA for each patent claimed invalid a statement why such patent will be infringed & response to BA‟s statements. Negotiate for 15 days after receipt Parties agree to list of patents that will be litigated first . If no agreement alternative procedure kicks in. Within 30 days after agreement RP sponsor shall bring action for Patent infringement Within 30 days of service BA provides secretary a notice and copy of compliant for publication in federal register. BA provides notice of commercial marketing to RP sponsor If there is no preliminary injunction awarded , BA may market the biosimilar. (Not latter that 180 days , during which time RP sponsor may seek preliminary injunction) 1/23/2014 29
  • No agreement reached with 15 days for regarding patent list BA notifies RP sponsor of the number of patents it plans to list in the alternative procedure‟s list exchange The parties simultaneously exchange lists of patents they believe should be litigated (RP sponsor may list at least 1, but otherwise no more patents than the BA lists) Within 5 days after notice Within 30 days after exchange RP Sponsor must bring suit with respect to every patent on both lists 1/23/2014 30
  •  Within 20 days after FDA notifies the biosimilar applicant that its application has been accepted for review, the biosimilar applicant must provide the reference product sponsor a copy of the application and information that describes the manufacturing process (otherwise, penalty provision applies). Drug Regulations : Online Resource for Latest Information 1/23/2014 31
  •  Access to the biosimilar application must be provided to: ◦ Outside counsel for the reference product sponsor (who do not engage in patent prosecution related to the reference product) ◦ One in-house lawyer for the reference product sponsor (who does not engage in patent prosecution related to the reference product) Drug Regulations : Online Resource for Latest Information 1/23/2014 32
  •  Access to the biosimilar application may also be provided to: ◦ A representative of a third-party patent owner ◦ Any others in the sole discretion of the biosimilar applicant Drug Regulations : Online Resource for Latest Information 1/23/2014 33
  •  Conditions attaching to confidential access: ◦ No disclosure without prior written consent ◦ Information may be used only for purpose of identifying relevant patents for list exchanges ◦ Confidentiality provisions govern until a court enters a protective order Drug Regulations : Online Resource for Latest Information 1/23/2014 34
  •  Within 60 days after receiving the biosimilar application, the reference product sponsor must ◦ Provide the biosimilar applicant with a list of patents for which it believes it (or a patent owner that has granted it an exclusive licence) could reasonably assert a claim of patent infringement ◦ Identify which of these patent(s) it would be prepared to license Drug Regulations : Online Resource for Latest Information 1/23/2014 35
  •  Within 60 days after receiving list, the biosimilar applicant ◦ May provide a list of patents for which it believes the reference product sponsor (or a patent owner that has granted it an exclusive licence) could reasonably assert a claim of patent infringement ◦ Must provide a detailed statement as to each patent identified by the reference sponsor or itself:  On claim-by-claim basis why such patent is invalid, unenforceable and/or not infringed, or  That it intends to wait for patent expiry Drug Regulations : Online Resource for Latest Information 1/23/2014 36
  •  Reference Product Sponsor must ◦ Respond to any offer to license within 60 after receiving list and statement. ◦ Provide, for each patent the biosimilar applicant challenges, a detailed statement, on a claim-by-claim basis, why such patent will be infringed ◦ Provide a response to the statement concerning validity and enforceableability Drug Regulations : Online Resource for Latest Information 1/23/2014 37
  •  For 15 days, the biosimilar applicant and reference product sponsor engage in good faith negotiations to agree on list of patent(s) for immediate litigation  If they agree, the reference sponsor has 30 days to bring an action for patent infringement on the listed patent(s) (otherwise, penalty provision applies) Drug Regulations : Online Resource for Latest Information 1/23/2014 38
  •  If they cannot agree on list of patent(s), the parties exchange lists of patents for immediate litigation: ◦ The biosimilar applicant specifies how many it will list ◦ Within 5 days, the parties exchange lists ◦ The reference product sponsor may list one patent, but otherwise no more than the number listed by the biosimilar applicant ◦ The reference sponsor has 30 days to bring an action for patent infringement on the listed patents (otherwise, penalty provision applies) Drug Regulations : Online Resource for Latest Information 1/23/2014 39
  •  Once the Complaint is served, the biosimilar applicant has 30 days to provide FDA with notice and a copy of the Complaint  FDA publishes the notice in the Federal Register Drug Regulations : Online Resource for Latest Information 1/23/2014 40
  •  Biosimilar applicant must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar  Reference product sponsor may seek a preliminary injunction on:  Any patent identified in the lists that were subject of initial exchanges, and  That was not included in the immediate litigation Drug Regulations : Online Resource for Latest Information 1/23/2014 41
  •  A court must enjoin infringement until patent expiry if: ◦ The patent was the subject of the immediate litigation process ◦ There is a final court decision that the patent is valid and infringed ◦ The 12-year data exclusivity period has not expired Drug Regulations : Online Resource for Latest Information 1/23/2014 42
  •  The reference product sponsor may recover only a reasonable royalty (ie, no injunction) if: ◦ It did not initiate patent litigation within 30 days of the creation of a list for immediate litigation ◦ It initiated litigation within 30 days, but the action was dismissed without prejudice or was not prosecuted in good faith Drug Regulations : Online Resource for Latest Information 1/23/2014 43
  •  The reference product sponsor may not enforce a patent with respect to the biosimilar product if: ◦ The patent should have been included on the reference product sponsor‟s initial or supplemental list and was not Drug Regulations : Online Resource for Latest Information 1/23/2014 44
  •  If the biosimilar applicant provides a copy of its application and manufacturing information to the describing reference product sponsor, then: ◦ Neither party may bring a declaratory judgment (DJ) action until the 180-day notice of commercial marketing with respect to a patent that was on either party‟s initial list and that was not included in the immediate litigation Drug Regulations : Online Resource for Latest Information 1/23/2014 45
  •  Penalty Provision: If the biosimilar applicant fails to provide a copy of its application and information describing manufacturing, then: ◦ Only the reference product sponsor can bring a DJ action with respect to any patent that claims the reference product or a use of the reference product Drug Regulations : Online Resource for Latest Information 1/23/2014 46
  •  Penalty Provision: If the biosimilar applicant fails to: ◦ Provide a statement in response to the reference sponsor‟s initial/supplemental list ◦ Provide a list of patents for immediate litigation after agreement ◦ could not be reached ◦ Provide notice of litigation and a copy of the Complaint to FDA ◦ Provide a detailed statement in response to notification of any newly issued or licensed patents ◦ Provide notice to the reference product sponsor 180 days before first commercial marketing of the biosimilar  Then, the reference product sponsor may bring a DJ action on any patent in its own initial or supplement lists Drug Regulations : Online Resource for Latest Information 1/23/2014 47
  •  If there is a newly issued or licensed patent to the reference product sponsor after it provides its initial list , then: ◦ Within 30 days, reference product sponsor must supplement its ◦ list and ◦ Within 30 days after receipt of supplemental list, the biosimilar applicant must:  On claim-by-claim basis why such patent is invalid, unenforceable and/or not infringed, or  That it intends to wait for patent expiry ◦ Otherwise, penalty provision applies Drug Regulations : Online Resource for Latest Information 1/23/2014 48
  •  Scientific Considerations in Demonstrating Biosimilarity to a Reference Product  Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product  Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009  Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants Drug Regulations : Online Resource for Latest Information 1/23/2014 49
  •  FDA has not to issued separate guidances in different drug product classes.  Sponsors are permitted to use a non-US licensed comparator in certain studies, with appropriate associating data. Drug Regulations : Online Resource for Latest Information 1/23/2014 50
  •  This presentation was compiled from freely available resources like the websites of FDA, EMA, WHO.  “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.  Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. Drug Regulations : Online Resource for Latest Information 1/23/2014 51