Biosimilar & Patents - Challenges for Research & Analysis

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Title: Biosimilar & Patents - Challenges for Research & Analysis
IKS Category: Biopharmaceutical and Patenting
IKS Article No: IKS_Biopharma_01 Rev_1_July_20_2017
Compilation by: Mayuri Butani; Pritesh Gohel; Chintan Modi; Tejas Patel
Why This Series?
Technology is shaping the world around us. Every day we come across
the new ideas and new technology. We believe in “WE SHARE, WE
GROW”. We believe in sharing what we learn and learning further by
receiving your feedback on IKS@intellectperitus.com
Why This Article?
We learned that Biosimilar is an area in which searching prior art is a
challenge. We accepted this challenge and we learned what the related
areas are which pose challenges and what can be the remedies around
those challenges.
Our Disclaimer:
We undergo rigorous study of various materials available in books,
journals, conference proceedings, trade magazines, catalogs/manuals,
blogs and general web search. We have provided references as much as
possible. Feel free to contact us if you believe that we have used any
copyrighted material without providing references. We apologize.

CONTENTS:
1. Abstract ............................................................................................................................ 3
2. Introduction to Biosimilar: ............................................................................................... 4
2.1. Biological Products, Biosimilar and Interchangeable ............................................... 4
2.2. Why biosimilars are not considered as generic medicines?.................................... 5
3. Biosimilar in USA:............................................................................................................ 6
3.1. Biologics Price Competition and Innovation Act 2009.............................................. 6
3.2. Biosimilar Interchangeability:...................................................................................... 7
3.3. The “Purple Book”: ...................................................................................................... 8
3.4. Biosimilars Approved in USA:..................................................................................... 8
4. Biosimilar in Europe: ....................................................................................................... 9
4.1. Legislation Directive 2001/83/EC............................................................................... 9
4.2. Biosimilar Interchangeability:.................................................................................... 10
4.3. Biosimilars Approved in Europe: .............................................................................. 11
5. Biosimilar in India: ......................................................................................................... 12
5.1. CSIR Guidelines: ....................................................................................................... 12
5.2. Biosimilars Approved in India: .................................................................................. 12
6. Patent Research & Analytics Challenges for Biosimilars:.......................................... 13
References: ........................................................................................................................... 14
About IntellectPeritus............................................................................................................ 15

Biosimilar & Patents - Challenges for Research & Analysis
1. Abstract
By 2020, it is predicted that the Biosimilar market globally will cross US$20 Billion. With
an increasing number of patent expires and more clear regulation processes, Biosimilars
have emerged as one of the fastest-growing categories in the biopharmaceutical sector.
The increasing need for cost-effective treatment is one of the major factors driving this
market‟s growth in the coming years. Biosimilars cost 10% to 30% lesser than their
parent products which is one of the primary factors fueling their adoption. This article
mainly focuses on what is Biosimilar, overview of regulation, products approved related
to Biosimilar in USA, Europe & India and few challenges in patent researching and
analysis related to Biosimilars.

2. Introduction to Biosimilar:
2.1. Biological Products, Biosimilar and Interchangeable
2.1.1. 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.
Many of today‟s important medications are biological products. Biological products are
among the medications used to treat conditions such as rheumatoid arthritis, anemia,
Alzheimer‟s disease, multiple sclerosis, low white blood cell counts, inflammatory bowel
disease, skin conditions such as psoriasis, various forms of cancer and other serious
diseases.
Types of Biological products are: blood and blood products, proteins, vaccines,
allergenic extracts, human cells and tissues used for transplantation, gene and cellular
therapies. [1] Table 1 lists the example of biological products with technology
classification.
Name
Trade
Name
Technology Indication
Erythropoietin Epogen Recombinant protein
Anemia arising from cancer
chemotherapy, chronic renal
failure,
Etanercept Enbrel
Recombinant human
TNF-receptor fusion
protein
Rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis,
psoriasis
Adalimumab Humira Monoclonal antibody
Rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis,
psoriasis, ulcerative colitis,
Crohn's disease
Table 1: Example of Biological Products
2.1.2. Biosimilar:
Biosimilars are a type of biological products that are approved by regulatory authorities
because they are highly similar to an already approved biological product, known as the
biological reference product and have been shown to have no clinically meaningful
differences from the reference product. Minor differences in clinically inactive
components are allowed, but there must be no clinically meaningful differences between
the biosimilar and the reference product when it compared in terms of the safety, purity
and potency of the product. [2, 3]
2.1.3. Interchangeable:
An Interchangeable biological product is biosimilar to the reference product that meets
additional standards for interchangeability and is expected to produce the same clinical
result as of the reference product in any given patient, and for a product that is given to a

patient more than once, the risk in terms of safety and effectiveness of alternating or
switching between the interchangeable and the reference product is not greater than the
risk of using the reference product without alternating or switching. [2]
2.2.Why biosimilars are not considered as generic medicines?
A biosimilar is not regarded as a generic of a biological medicine. This is mostly because
the natural variability and more complex manufacturing of biological medicines do not
allow an exact replication of the molecular microheterogeneity. The 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. [1, 4, 6]Table 2 lists the differences
between the generic medicine vs. Biosimilar medicine.
Table 2: Comparison between Generics and biosimilars [1, 4, 5, 6]
Generic Medicine Biosimilar Medicine
Size Smaller molecules
Larger, structurally more complex
molecules
Characterization Easier to characterize
Require multiple technologies for their
characterization
Source
Usually produced by chemical
synthesis
Obtained from a biological source
Production Generally possible to obtain
exactly the same molecule
Possible to reproduce the molecule to a
high degree of similarity due to unique
bio-manufacturing methods and natural
biological variability
Pre-approval
Clinical data requirements are
mainly pharmacokinetic
bioequivalence studies
In addition to comparative
pharmacokinetic and pharmaco-
dynamic studies, safety and efficacy
data may be required, particularly for
more complex biological medicines
Structure

3. Biosimilar in USA:
3.1.Biologics Price Competition and Innovation Act 2009
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) which is
amendment to Public Health Service Act (PHS Act) creates an abbreviated licensure
pathway for biological products that are demonstrated to be “biosimilar” to or
“interchangeable” with an FDA-licensed biological product (42 U.S.C. §262(k)). [2]
As per 42 U.S.C. §262(k)(2) the manufacturers must submit a 351(k) biologics license
application (BLA) that includes, among other things, information demonstrating
biosimilarity based upon:
• Analytical studies demonstrating that the biological product is “highly similar” to
the reference product notwithstanding minor differences in clinically inactive
components
• Animal studies (including the assessment of toxicity)
• A clinical study or studies (including the assessment of immunogenicity and
pharmacokinetics (PK) or pharmacodynamics (PD)) sufficient to demonstrate
safety, purity, and potency in 1 or more appropriate conditions of use for which
the reference product is licensed and for which licensure is sought for the
biosimilar product. [2]
The BPCI Act (42 U.S.C. §262(k)(7)) provides reference biological drug products 12
years of marketing exclusivity for new “biological structures”. If a biosimilar application is
filed by the same manufacturer of the pioneer product (or a related party), the changed
biological structure must also result in
• Change in indications, route of administration, dosing schedule, dosing form,
delivery system, delivery device or strength
• Change in safety, purity or potency, new 12-year exclusivity period is to be
awarded [2]
An application for Interchangeable can file after four years of biologic structure (12-year)
exclusivity. [2]
Once the first interchangeable product has been approved, no subsequent
interchangeable applications will be approved until one year after the first commercial
marketing of interchangeable biosimilar biological product. This Timeline is extendable in
case of litigation (42 U.S.C. §262(k)(6)). [2]
The pediatric exclusivity under the BPCI Act adds six months to 12-year exclusivity and
six months to the four-year filing restriction (42 U.S.C. §262(m)(3)). [2]
As per 42 U.S.C. §262(i)(1) the Biosimilar applicant learns of the patents that protect the
pioneer biologic only after providing the pioneer with confidential access to its application
and related manufacturing process. The biosimilar applicant and pioneer then undertake

a complex exchange of patent information (the “patent dance”) over an approximate
two-month period to compile a list of “agreed to” patents that will be subject to a “first
wave” of pre-launch litigation. The pioneer then has 30 days to file suit on those patents
to enjoin biosimilar launch or else only royalties can be obtained in subsequent litigation
on those patents.
The U.S. Supreme Court on June 12, 2017 interpreted the BPCI act such that the
biosimilar patent dance is not mandatory in SANDOZ INC. v. AMGEN INC. ET AL. The
Supreme Court decided that Applicant of Biosimilar did not violate the BPCI Act by failing
to engage in the patent dance, as consequences for failure to do so are expressly stated
in the BPCI Act – meaning that failure to participate was expressly contemplated by the
BPCI Act. The Court explained that failing to disclose its application and manufacturing
information as required under 42 U.S.C. §262 (l)(2)(A) does not constitute an act of
artificial infringement, but is actionable under 42 U.S.C. §262 (l)(9)(C), which permits the
sponsor to bring an immediate declaratory judgment action for artificial infringement. [7]
The BPCI Act also provides for a “second wave” of pre-launch litigation by requiring the
biosimilar applicant to notify the pioneer a second time at least 180 days prior to launch.
Patents that were disclosed, but not on the “agreed to” list during the first dance, are
eligible for possible injunctive relief, and applicants can file Declaratory Judgments
during this second wave on patents that the pioneer elects not to pursue (42 U.S.C. §262
(i)(8)). [2, 7]
3.2.Biosimilar Interchangeability:
The USFDA on January 17, 2017 released a draft guidance detailing the agency's
expectations for demonstrating biosimilar interchangeability.
FDA proposed Biosimilar applicant should consider an array of factors ("totality of
factors") when determining the type and amount of data to support a demonstration of
interchangeability, including product complexity and product-specific immunogenicity
risk.
According to FDA, switching studies should be designed to determine whether
alternating between a biosimilar and its reference product two or more times impacts the
safety or efficacy of the treatment course. However, if the product is only intended to be
administered once, Biosimilar applicant may instead provide a justification for not
needing to conduct a switching study.
FDA also says that Biosimilar applicant should carefully consider their product
presentation, including the delivery device and container closure system, as differences
in presentation may affect FDA's determination of interchangeability. Applicant should
not try to get an interchangeable biosimilar approved with a different type of presentation
than the reference product. [8]

3.3.The “Purple Book”:
The “Purple Book” lists biological products, including any biosimilar and interchangeable
biological products, licensed by FDA under the Public Health Service Act (the PHS Act).
The Purple Book includes the date a biological product was licensed and whether FDA
evaluated the biological product for reference product exclusivity. The Purple Book, in
addition to the date licensed, also includes whether a biological product has been
determined by FDA to be biosimilar to or interchangeable with a reference biological
product (an already-licensed FDA biological product) [9]
3.4.Biosimilars Approved in USA:
Table 3 lists biological products approved in USA.
Biosimilar Product Reference Product Date of Approval
Filgrastim-sndz / Zarxio / Sandoz Filgrastim / Neupogen / Amgen March 6, 2015
Infliximab-dyyb / Inflectra / Celltrion Infliximab / Remicade / Janssen April 5, 2016
Etanercept-szzs / Erelzi / Sandoz Etanercept / Enbrel / Amgen August 30, 2016
Adalimumab-atto / Amjevita / Amgen Adalimumab / Humira / AbbVie September 23, 2016
Infliximab-abda / Renflexis / Samsung
Bioepsis
Infliximab / Remicade / Janssen April 21, 2017
Table 3: Biosimilars approved in USA [10]

4. Biosimilar in Europe:
4.1.Legislation Directive 2001/83/EC
The EU has pioneered the regulation of biosimilars since the approval of the first one
(the growth hormone somatropin) in 2006 with legislation Directive 2001/83/EC, as
amended (2004/27/EC) in March 2004: Article 10.4. [11]Since biosimilars are a type of
biological medicine, all features pertinent to biological medicines apply.
The biosimilar has physical, chemical and biological properties highly similar to that of
the reference medicines. There may be minor differences from the reference medicine
which are not clinically meaningful in terms of safety or efficacy. Minor variability is only
allowed when scientific evidence shows that it does not affect the safety and efficacy of
the biosimilar. The range of variability allowed for a biosimilar is the same as that allowed
between batches of the reference medicine. This is achieved with a robust
manufacturing process to ensure that all batches of the medicine are of proven quality.
[4]
The exclusivity period provision in Europe is the same for both biologics and chemical
drugs. All medicines produced using biotechnology and those for specific indications
(e.g. for cancer, neurodegeneration and auto-immune diseases) must be approved in the
EU through EMA (European Medicines Agency) also known as „centralized procedure‟.
Nearly all biosimilars approved for use in the EU have been approved centrally, as they
use biotechnology for their production. Some biosimilars may be approved at national
level, such as some low-molecular weight heparins derived from porcine intestinal
mucosa. [4]
When a company applies for marketing authorization at EMA, data are evaluated by
EMA‟s scientific committees on human medicines and on safety (the CHMP and PRAC),
as well as by EU experts on biological medicines (Biologics Working Party) and
specialists in biosimilars (Biosimilar Working Party). The review by EMA results in a
scientific opinion, which is then sent to the European Commission, which ultimately
grants an EU-wide marketing authorization. Image 1 depicts steps of Biosimilar
development. [4]
Image 1: Biosimilar Development in steps [4]

4.2.Biosimilar Interchangeability:
The terminology to refer to interchangeability and substitution practices in the EU:
Interchangeability refers to the possibility of exchanging one medicine for another
medicine that is expected to have the same clinical effect. This could mean replacing a
reference product with a biosimilar (or vice versa) or replacing one biosimilar with
another. Replacement can be done by:
• Switching (Physician Decision) - the prescriber decides to exchange one
medicine for another medicine with the same therapeutic intent.
• Substitution (automatic) (Pharmacist action) - practice of dispensing one
medicine instead of another equivalent and interchangeable medicine at
pharmacy level without consulting the prescriber.
As per provision EMA carries out the scientific review of a biosimilar, the evaluations do
not include recommendations on whether the biosimilar is interchangeable with the
reference medicine, and thus whether the reference medicine can be switched or
substituted with the biosimilar. The decision on whether to allow interchangeable use
and substitution of the reference biological medicine and the biosimilar is taken at
national level. [4]
There is convergence across EU countries that biologic medicines should not be
substituted at the pharmacy level without the involvement of the clinical decision maker.
[13] Image 2 provides switching policy in Biosimilars.
Image 2: Biosimilars switching policy [4]

4.3.Biosimilars Approved in Europe:
More than 25 biosimilars are approved in EU. Few of them are listed in Table 4 below:
Product
Active
Substance
Manufacturer /
Company
Authorization
Date
Reference
Drug
Binocrit
epotein alfa
Sandoz 28-Aug-07
Eprex / Erypo
Epoetin Alfa
Hexal
Hexal 28-Aug-07
Silapo
epotein zeta
Stada 18-Dec-07
Retacrit Hospira 18-Dec-07
Accofil
filgrastim
Accord 18-Sep-14
Neupogen
Filgrastim Hexal filgrastim 6-Feb-09
Nivestim Hospira 8-Jun-10
Zarzio Sandoz 6-Feb-09
Inhixa
enoxaparin
sodium
Techdow Europe 15-Sep-16
Clexane
Thorinane Pharmathen 15-Sep-16
Flixabi
Infliximab
Samsung Bioepis 26-May-16
RemicadeInflectra Hospira 10-Sep-13
Remsima Celltrion 10-Sep-13
Benepali etanercept Samsung Bioepis 14-Jan-16 Enbrel
Table 4: Biosimilars approved in Europe [14]

5. Biosimilar in India:
5.1.CSIR Guidelines:
The Central Drugs Standard Control Organization is the national regulatory body of India
released new guideline for biosimilars which is effective from August 15, 2016. The new
guideline is a slight change of the previous Biosimilars guideline “Draft Guidelines on
Similar Biologics: Regulatory Requirements for Marketing Authorization in India”
released in 2012. The 2012 Guideline on similar biologics address the pre-marketing and
post-marketing regulatory requirement (i.e. “comparability exercise”), and also address
the requirements related to manufacturing process and quality control. [15]
India has adopted a “sequential approach” (like “stepwise approach” - US and EU) to
market biosimilar products. The 2016 guidelines focus more on Post marketing. The
major change mentioned in new guideline is the Reference product. If the reference
product is not marketed in India, it can be licensed in any ICH country. [16]
5.2.Biosimilars Approved in India:
More than 25 biosimilars are approved in India. Few of them are listed in Table 5 below
Product
Active
Substance
Company Approval / Launch Date
Epofer
epoetin alfa
Emcure Not Reported
Epotin Claris Lifesciences Not Reported
Erypro Biocon Not Reported
Erykine
Intas
Biopharmaceuticals
August 2005
Wepox Wockhardt March 2001
Fegrast
Filgrastim
Claris Life Sciences Not Reported
Grafeel Dr. Reddy‟s Laboratories Not Reported
Neukine
Intas
Biopharmaceuticals
July 2004
Nufil Biocon Not Reported
Choriorel
Chorionic
gonadotrophin
Reliance Life Sciences Not Reported
Cresp Darbopoetin alfa Dr. Reddy‟s Laboratories August 2010
Table 5: Biosimilars approved in India [17]

6. Patent Research & Analytics Challenges for Biosimilars:
Patent research and analytics of Biosimilars is challenging and time-consuming because
of
• Complex structure and function of Biological molecules
• Various keywords for same biological molecule like brand name, generic name,
keywords based on target site, keywords based on mode of action, acronyms,
abbreviations, spelling variations and truncations, etc.
 For example: For Adalimumab, Keywords can be Adalimumab, Humira, Trudexa,
Amjevita, humanized monoclonal antibody, human monoclonal antibody, anti-
TNF mAb, anti-TNF monoclonal antibodie, D2E7 Heavy chain, D2E7 Light chain,
TNF-α, TNF-alpha, hTNFα, hTNF, TNFA, TNFSF2, etc.
• Like Chemical Structure search in chemical molecules, Sequence search (Nucleotide
and Protein) in Biosimilars is key and universal approach. Not only 100% match
sequence is relevant as chances are there that part of entire sequence is claimed.
Difficulties of determining fragment of sequence considered as relevant.
• Multiple assignees work on same Biosimilar and file patent applications. You need to
be very careful in collecting patent documents of all assignees considering in mind
complete corporate hierarchy of companies.
• Companies developing Biosimilars tend to file patent applications vigorously. One
patent family could be large to contain hundreds of patents and applications. The
family is having patent documents related to Biosimilar as well as all its possible
variations. Hence challenge is to isolate patent documents which are relevant for
Biosimilar of our interest.
 For Example, a patent family of US6090382 covering Humira (Adalimumab)
assigned to BASF contains 129 publications (INPADOC family members)
• Apart from product patent covering Biosimilar, we must take care of patents claiming
composition, Process of manufacturing / screening / purification / characterization,
method of use, etc. You must need to see expiry of all these.
 For example, For Adalimumab (Humira), product patent covering Adalimumab
expired in end of 2016, but still more than 70 patents are alive wherein 14 patents
are on Humira Formulation, more than 20 patents on method of manufacturing
and more than 20 patents on method of treatment.

References:
1. U.S. Food and Drug Administration. Consumer Updates: Regulating Biological Products; 2008.
Available from: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048341.htm
2. Office of the Law Revision Counsel; 42 USC § 262: Regulation of biological products.
3. European Medicines Agency. Overview: Biosimilar Medicines. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp&
mid=WC0b01ac0580bb8fda
4. European Medicines Agency. Information guide for healthcare professionals: Biosimilars in the EU;
2017. Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
5. Sekhon SB, Saluja V; Biosimilars: An overview; Biosimilars, Volume: 2011, Issue:1, Pages:1-11; 2011.
6. Müller R, Renner C, Gabay C, Cassata G, Lohri A, Hasler P; The advent of biosimilars: Challenges and
risks; Swiss Medical Weekly, Volume: 144:w13980; 2014.
7. Supreme Court of the United States. Sandoz INC. v. AmgeN INC. et al.; Syllabus, No.: 15-1039; June
12, 2017.
8. US Food and Drug Administration. Draft Guidance, Guidance for Industry: Considerations in
Demonstrating Interchangeability with a Reference Product; January 2017. Available from:
Product.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM537135.pdf
9. US Food and Drug Administration. Purple Book: Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Available from:
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvala
pplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm
10. US Food and Drug Administration. Center for Drug Evaluation and Research: List of Licensed Biological
Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to
Date. Available
from:https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand
Approved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf
11. Official Journal of the European Union. The European Parliament, Directive 2004/27/EC; March 31,
2004. Available from: http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-
1/dir_2004_27/dir_2004_27_en.pdf
12. European Medicines Agency. Data exclusivity / Generics / Biosimilars: Regulatory and procedural
guidance; 2008. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000
211.jsp&mid=WC0b01ac0580031b0a
13. Medicines for Europe. Biosimilar Medicines, Memo: Positioning Statements on Physician-led Switching
for Biosimilar Medicines; April 2017. Available from: http://www.medicinesforeurope.com/wp-
content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf
14. European Medicines Agency. European public assessment reports: Biosimilars. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&m
id=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&st
atus=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searc
hGenericType=biosimilars
15. Government of India, Department of Biotechnology, Central Drugs Standard Control Organization.
Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2012.
Available from: http://www.cdsco.nic.in/writereaddata/Bio%20Similar%20Guideline.pdf
16. Government of India, Department of Biotechnology, Central Drugs Standard Control Organization.
Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2016.
Available from: http://www.ableindia.in/images/resources/1471597420-
Guidelines%20on%20Similar%20Biologics%20wef%2015%20Aug%202016.pdf
17. GaBI Online - Generics and Biosimilars Initiative. „Similar biologics‟ approved and marketed in India;
September 9, 2012. Available from: http://www.gabionline.net/Biosimilars/General/Similar-biologics-
approved-and-marketed-in-India

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