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India’s New Similar Biologic Guidelines: An Overview




   Corporate Lawyer Law Firm India New
   Delhi Kale Law Office Corporate Lawyer
   Law Firm India New Delhi Kale Law
   Office

   Corporate Lawyer Law Firm India New
   Delhi Kale Law Office

   Corporate Lawyer Law Firm India New
   Delhi Kale Law Office

   Corporate Lawyer Law Firm India New
   Delhi Kale Law Office

   Corporate Lawyer Law Firm India New
   Delhi Kale Law Office

   Corporate Lawyer Law Firm India New
   Delhi Kale Law Office
he Indian Ministry of Health and Family Welfare and Science and


T
       Technology had earlier in the month of June released their guidelines on
       biosimilars (similar bilologis in the Indian context) to be implemented
       from August 15 2012. These guidelines bring an end to the era of ad-hoc
       abbreviated approval pathway under which the Indian authorities had
been approving Indian produced generic biologics with reference products
which were approved in the United States and Europe. There have also been
instances, where biotechnology products were approved without conducting
clinical trials on enough number of patients. The guidelines are applicable for
similar biologics developed in India or imported into the country
The 52-page document, titled, ‘Guidelines on Similar Biologics: Regulatory
Requirements for Marketing Authorization in India’ covers both biosimilars
developed in India as well as those imported into the country. The proposed
norms outline specific requirements for pre-marketing and post-marketing data
apart from guidelines for pre-clinical and clinical trials for biosimilars. The
Indian Guidance lays out the same kind of stepwise approach, starting with
detailed structural characterization of the proposed biosimilar and its reference
product, followed by preclinical then clinical characterizations, and makes
allowances for product-specific differences in analytical techniques and clinical
endpoints.

Salient Features

Definition of Similar Biologics and its Development


As per the guidelines, similar              In case the reference biologic is not
biologic includes: a biological             authorized in India it should have
product or drug produced by                 been licensed and marketed for at
genetic engineering techniques and          least 4 years with significant safety
claimed to be "similar" in terms of         and efficacy data. Under present
quality, safety, efficacy to a              circumstances, these guidelines
reference innovator product, which          seem to be clearly aimed at
has been granted a marketing                encouraging more investment in
authorization in India by a                 biosimilars in India, both by
competent authority on the basis of         domestic and foreign companies.
a complete dossier, and with a              However, in case of no medicine or
history of safe use in India. The           only palliative therapy is available
definition of similar biologics shows       or     in    national     healthcare
that under the regulatory regime a          emergency, this period of 4 years
product can be considered as                may be reduced or waived off.
similar biologic only if it is proven       Since for the foreseeable future,
to be similar, using extensive              new biologics will be predominantly
quality characterization against the        pioneered in the U.S. and Europe,
reference biologic.                         there will be a number of recently-
                                            developed products that fall into



                                                                                    1
this category, and will await either
the approval of the reference drug
in India, or the passage of four
years after approval elsewhere.

Clinical Trials

The guideline suggests that under certain circumstances biosimilars can be
approved without involved clinical trials: The confirmatory clinical safety and
efficacy study can be waived if all the below mentioned conditions are met:




       i. Structural and functional comparability of similar biologic and
       reference biologic can be characterized to a high degree of confidence by
       physicochemical and in vitro techniques

       ii. The similar biologic is comparable to reference biologic in all
       preclinical evaluations conducted

       iii. PK / PD study has demonstrated comparability and has
       preferentially been done in an in patient setting with safety
         referentially                         in‐patient
       measurement         (including immunogenicity) for adequate period
       justified by the applicant and efficacy measurements

       iv. A comprehensive post marketing risk management plan has been
                           post‐marketing
       presented that will gather additional safety data with a specific
       emphasis on gathering immunogenicity data

       The confirmatory clinical safety and efficacy study cannot be waived if
       there is no reliable and validated PD marker.




                                                                                   2
COMPARATIVE ANALYSIS

1.      Definition of Biosimilar (Similar Biologics)
INDIA                          UNITED STATES                  EUROPE

                               35 U.S.C § 262 (i)             Biosimilarity is not explicitly
“A biological product/         Highly similar to a            defined, but is situational:
drug produced by genetic       reference product licensed     “Whether a medicinal
engineering techniques         under 262(a)                   product would be acceptable
and claimed to be              notwithstanding minor          using the ‘similar biological
“similar” in terms of          differences in clinically      medicinal product’ approach
safety, efficacy and quality   inactive components.           depends on the state of the
to a reference biologic,       35 U.S.C § 262 (k)–            art of analytical procedures,
which has been granted a       Demonstrated                   the manufacturing processes
marketing authorization        biosimilarity to reference     employed, as well as clinical
in India by DCGI on the        based upon: Analytical         and regulatory
basis of a complete            studies to show highly         experiences.” CHMP/437/04.
dossier, and with a            similar, Animal studies,       “Comparability studies are
history of safe use in         and Clinical study(ies)        needed to generate evidence
India.” Indian Guidelines                                     substantiating the similar
at 22.                                                        nature, in terms of quality,
                                                              safety and efficacy, of the
                                                              new similar biological
                                                              medicinal product and the
                                                              chosen reference medicinal
                                                              product authorised in the
                                                              Community.” CHMP/437/04

2. Developing a Biosimilar
INDIA                           UNITED STATES                  EUROPE
Similar biologics are           A stepwise approach to         “A stepwise approach
developed through               demonstrating                  should be undertaken to
sequential process to           biosimilarity, which can       justify any differences in
demonstrate the similarity      include a comparison of        the quality attributes of the
by extensive                    the proposed product and       similar biological medicinal
characterization studies        the reference product with     product versus the
revealing the molecular         respect to structure,          reference medicinal
and quality attributes with     function, animal toxicity,     product in order to make a
regard to the reference         human pharmacokinetics         satisfactory justification of
biologic. Indian Guidelines     (PK) and                       the potential implications
at 5.                           pharmacodynamics (PD),         with regard to the safety
                                clinical immunogenicity,       and efficacy of the
                                and clinical safety and        product.”
                                effectiveness Guidance         CHMP/BWP/49348/2005
                                “Scientific Considerations”    at 5.
                                at 2.




                                                                                                3
3. Reference Products
INDIA                        UNITED STATES                   EUROPE
 Licensed in India or in     “To obtain licensure … a        No provision for non-EMA
“Similar biologic can only   sponsor must demonstrate        licensed reference
be developed against an      that the proposed product       products.
authorized reference         is biosimilar to a single
biologic that has been       reference product that
approved using a complete    previously has been
data package in India. In    licensed by FDA. . . .
case the reference biologic  However, under certain
is not authorized in India,  circumstances, a sponsor
it should have been          may seek to use data
licensed and marketed for    derived from animal or
at least 4 years with        clinical studies comparing
significant safety and       a proposed product with a
efficacy data.” Indian       non-U.S.-licensed
Guidelines at 3.             product….. In such a case,
                             the sponsor should provide
“The products, where the     adequate data or
reference biologic is not    information to scientifically
authorized in India shall be justify the relevance of this
considered on a case by      comparative data to an
case basis if such products assessment of biosimilarity
have been granted            and to establish an
marketing approval in        acceptable bridge to the
countries with well          U.S.-licensed reference
established regulatory       product.” Guidance for
systems such as US FDA,      Industry Scientific
EMA etc. and have been in Considerations in
wider use for a minimum of Demonstrating
four years.” Id. at. 22      Biosimilarity to a Reference
                             Product at 6




                                                                                        4
4. Safety and Efficacy Trials
INDIA                  UNITED STATES                        EUROPE
Potential for          “As a scientific matter,             “Usually comparative
omission of safety     comparative safety and               clinical trials will be
and efficacy trials.   effectiveness data will be           necessary to demonstrate
See quote above        necessary to support a               clinical comparability
                       demonstration of biosimilarity if    between the similar
                       there are residual uncertainties     biological and the reference
                       about the biosimilarity of the two   medicinal product.”
                       products based on structural         EMEA/CHMP/BMWP/4283
                       and functional characterization,     2/2005 at 6.
                       animal testing, human PK and
                       PD data, and clinical
                       immunogenicity assessment. A
                       sponsor may provide a scientific
                       justification if it believes that
                       some or all of these comparisons
                       on clinical safety and
                       effectiveness are not necessary.”
                       FDA Draft Guidance for
                       Industry:
                       Scientific Considerations in
                       Demonstrating Biosimilarity to a
                       Reference Product at 12.



   5. Exclusivity Period
INDIA                        UNITED STATES                  EUROPE
India provides for no        A section (k) application      “8+2+1.”      A    biosimilar
market exclusivity period    may not be filed until 4       application may not be
beyond patent rights.        years     after   reference    filed until 8 years after the
                             product      approval.    A    reference product approval.
                             biosimilar may not be          A biosimilar may not be
                             approved until 12 years        approved until 10 years
                             after reference     product    after reference approval.
                             approval. 42    USC     262    The market exclusivity may
                             (k)(7).                        be     extended     by     an
                                                            additional year if the
                                                            reference product sponsor
                                                            obtains approval for a
                                                            second     significant   new
                                                            indication during the data
                                                            exclusivity period.




                                                                                            5

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India’s new similar biologic guidelines an overview

  • 1. India’s New Similar Biologic Guidelines: An Overview Corporate Lawyer Law Firm India New Delhi Kale Law Office Corporate Lawyer Law Firm India New Delhi Kale Law Office Corporate Lawyer Law Firm India New Delhi Kale Law Office Corporate Lawyer Law Firm India New Delhi Kale Law Office Corporate Lawyer Law Firm India New Delhi Kale Law Office Corporate Lawyer Law Firm India New Delhi Kale Law Office Corporate Lawyer Law Firm India New Delhi Kale Law Office
  • 2. he Indian Ministry of Health and Family Welfare and Science and T Technology had earlier in the month of June released their guidelines on biosimilars (similar bilologis in the Indian context) to be implemented from August 15 2012. These guidelines bring an end to the era of ad-hoc abbreviated approval pathway under which the Indian authorities had been approving Indian produced generic biologics with reference products which were approved in the United States and Europe. There have also been instances, where biotechnology products were approved without conducting clinical trials on enough number of patients. The guidelines are applicable for similar biologics developed in India or imported into the country The 52-page document, titled, ‘Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India’ covers both biosimilars developed in India as well as those imported into the country. The proposed norms outline specific requirements for pre-marketing and post-marketing data apart from guidelines for pre-clinical and clinical trials for biosimilars. The Indian Guidance lays out the same kind of stepwise approach, starting with detailed structural characterization of the proposed biosimilar and its reference product, followed by preclinical then clinical characterizations, and makes allowances for product-specific differences in analytical techniques and clinical endpoints. Salient Features Definition of Similar Biologics and its Development As per the guidelines, similar In case the reference biologic is not biologic includes: a biological authorized in India it should have product or drug produced by been licensed and marketed for at genetic engineering techniques and least 4 years with significant safety claimed to be "similar" in terms of and efficacy data. Under present quality, safety, efficacy to a circumstances, these guidelines reference innovator product, which seem to be clearly aimed at has been granted a marketing encouraging more investment in authorization in India by a biosimilars in India, both by competent authority on the basis of domestic and foreign companies. a complete dossier, and with a However, in case of no medicine or history of safe use in India. The only palliative therapy is available definition of similar biologics shows or in national healthcare that under the regulatory regime a emergency, this period of 4 years product can be considered as may be reduced or waived off. similar biologic only if it is proven Since for the foreseeable future, to be similar, using extensive new biologics will be predominantly quality characterization against the pioneered in the U.S. and Europe, reference biologic. there will be a number of recently- developed products that fall into 1
  • 3. this category, and will await either the approval of the reference drug in India, or the passage of four years after approval elsewhere. Clinical Trials The guideline suggests that under certain circumstances biosimilars can be approved without involved clinical trials: The confirmatory clinical safety and efficacy study can be waived if all the below mentioned conditions are met: i. Structural and functional comparability of similar biologic and reference biologic can be characterized to a high degree of confidence by physicochemical and in vitro techniques ii. The similar biologic is comparable to reference biologic in all preclinical evaluations conducted iii. PK / PD study has demonstrated comparability and has preferentially been done in an in patient setting with safety referentially in‐patient measurement (including immunogenicity) for adequate period justified by the applicant and efficacy measurements iv. A comprehensive post marketing risk management plan has been post‐marketing presented that will gather additional safety data with a specific emphasis on gathering immunogenicity data The confirmatory clinical safety and efficacy study cannot be waived if there is no reliable and validated PD marker. 2
  • 4. COMPARATIVE ANALYSIS 1. Definition of Biosimilar (Similar Biologics) INDIA UNITED STATES EUROPE 35 U.S.C § 262 (i) Biosimilarity is not explicitly “A biological product/ Highly similar to a defined, but is situational: drug produced by genetic reference product licensed “Whether a medicinal engineering techniques under 262(a) product would be acceptable and claimed to be notwithstanding minor using the ‘similar biological “similar” in terms of differences in clinically medicinal product’ approach safety, efficacy and quality inactive components. depends on the state of the to a reference biologic, 35 U.S.C § 262 (k)– art of analytical procedures, which has been granted a Demonstrated the manufacturing processes marketing authorization biosimilarity to reference employed, as well as clinical in India by DCGI on the based upon: Analytical and regulatory basis of a complete studies to show highly experiences.” CHMP/437/04. dossier, and with a similar, Animal studies, “Comparability studies are history of safe use in and Clinical study(ies) needed to generate evidence India.” Indian Guidelines substantiating the similar at 22. nature, in terms of quality, safety and efficacy, of the new similar biological medicinal product and the chosen reference medicinal product authorised in the Community.” CHMP/437/04 2. Developing a Biosimilar INDIA UNITED STATES EUROPE Similar biologics are A stepwise approach to “A stepwise approach developed through demonstrating should be undertaken to sequential process to biosimilarity, which can justify any differences in demonstrate the similarity include a comparison of the quality attributes of the by extensive the proposed product and similar biological medicinal characterization studies the reference product with product versus the revealing the molecular respect to structure, reference medicinal and quality attributes with function, animal toxicity, product in order to make a regard to the reference human pharmacokinetics satisfactory justification of biologic. Indian Guidelines (PK) and the potential implications at 5. pharmacodynamics (PD), with regard to the safety clinical immunogenicity, and efficacy of the and clinical safety and product.” effectiveness Guidance CHMP/BWP/49348/2005 “Scientific Considerations” at 5. at 2. 3
  • 5. 3. Reference Products INDIA UNITED STATES EUROPE Licensed in India or in “To obtain licensure … a No provision for non-EMA “Similar biologic can only sponsor must demonstrate licensed reference be developed against an that the proposed product products. authorized reference is biosimilar to a single biologic that has been reference product that approved using a complete previously has been data package in India. In licensed by FDA. . . . case the reference biologic However, under certain is not authorized in India, circumstances, a sponsor it should have been may seek to use data licensed and marketed for derived from animal or at least 4 years with clinical studies comparing significant safety and a proposed product with a efficacy data.” Indian non-U.S.-licensed Guidelines at 3. product….. In such a case, the sponsor should provide “The products, where the adequate data or reference biologic is not information to scientifically authorized in India shall be justify the relevance of this considered on a case by comparative data to an case basis if such products assessment of biosimilarity have been granted and to establish an marketing approval in acceptable bridge to the countries with well U.S.-licensed reference established regulatory product.” Guidance for systems such as US FDA, Industry Scientific EMA etc. and have been in Considerations in wider use for a minimum of Demonstrating four years.” Id. at. 22 Biosimilarity to a Reference Product at 6 4
  • 6. 4. Safety and Efficacy Trials INDIA UNITED STATES EUROPE Potential for “As a scientific matter, “Usually comparative omission of safety comparative safety and clinical trials will be and efficacy trials. effectiveness data will be necessary to demonstrate See quote above necessary to support a clinical comparability demonstration of biosimilarity if between the similar there are residual uncertainties biological and the reference about the biosimilarity of the two medicinal product.” products based on structural EMEA/CHMP/BMWP/4283 and functional characterization, 2/2005 at 6. animal testing, human PK and PD data, and clinical immunogenicity assessment. A sponsor may provide a scientific justification if it believes that some or all of these comparisons on clinical safety and effectiveness are not necessary.” FDA Draft Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product at 12. 5. Exclusivity Period INDIA UNITED STATES EUROPE India provides for no A section (k) application “8+2+1.” A biosimilar market exclusivity period may not be filed until 4 application may not be beyond patent rights. years after reference filed until 8 years after the product approval. A reference product approval. biosimilar may not be A biosimilar may not be approved until 12 years approved until 10 years after reference product after reference approval. approval. 42 USC 262 The market exclusivity may (k)(7). be extended by an additional year if the reference product sponsor obtains approval for a second significant new indication during the data exclusivity period. 5