Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics
Abstract
:1. Introduction
2. History, Scope and Evolution of Biotechnology Companies in India
3. Methodology
4. Global vs. Indian Biotech Endeavors
5. Market size and Current Scenario of Indian Biotech Companies in Biopharma Sector
6. Healthcare Scenario, Translational Research—Initiatives, Prospects and Bottlenecks
7. What Ails Indian Biotech Going Global?
7.1. SWOT Analysis of Indian Biotechnology Industry in General and Biosimilars in Particular
7.2. Lack of Innovation
7.3. Lack of Ventures
7.4. Loose Ignition Grant System
7.5. Lack of Leadership Vision
7.6. Quality Human Resource
7.7. Status of Industry-Academia Partnering
7.8. Mindset Issues—Need to Embrace the State-of-Art Technologies
7.9. Lack of Internal (Industry-Exposed) Expertise
7.10. Budget-Funding
7.11. Market Needs and Response to Competitive Pressures
- 1.
- Interchangeability: FDA needs ‘an interchangeable biological product which is similar to an existing FDA-approved reference product’. This allows substitution of the reference product with the interchangeable biologic by a pharmacist without the interference of the clinician who prescribed the reference biologic [114].
- 2.
- Naming: WHO follows the International Non-proprietary Name (INN) for generic products. Several other countries have adopted their unique naming convention. EU follows INN while Japan adopt INN with BS as suffix, US also follows INN with four-letter suffixes [115].
- 3.
- Labelling: After approval, the insert should clearly indicate whether the data were generated on a similar biologic or innovator product, including differences in characterization and the extent of similarity with the reference biologic on safety, immunogenicity, and efficacy for the awareness of patient and professionals. Moreover, the COOL (country of origin labelling) law applies, since 2003 [116].
7.12. Filling the Gaps in International B2B and B2C Collaborations, and Handholding
7.13. Lack of Diversification
7.14. Regulatory Affairs and IPR
8. Indian Vaccines in the Global Market
9. Visionary Perspective and Conclusion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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Triggering Factor | Beneficiary Organisation | Speciality Area | References |
---|---|---|---|
Scientists or local individual from various industrial sectors | XCyton Diagnostics (Bengaluru) | Diagnostics | [21] |
GangaGen (Bengaluru) | Antimicrobials | ||
Shanta Biotechnics (Hyderabad)–now part of Sanofi | Biogenerics, diagnostics, contract research | ||
Cytogenomics (Bengaluru) | Bioinformatics | ||
Bigtec (Bengaluru) Brilliant Bio Pharma Private Limited (Hyderabad) | Bioinformatics Veterinary Vaccines | ||
Companies venturing into biotech | Serum Institute of India (Pune) | Vaccines, biosimilars | [21] |
Biocon (Bengaluru) | Generics, biologics, biosimilars | ||
Infosys (Bengaluru); Tata Consultancy Services (Mumbai) | Bioinformatics | ||
Zydus Cadila | Generics, biologics, biosimilars | ||
Bioogical E (Hyderabad) | Vaccines. Biologics | ||
Intas Pharmaceuticals (Ahmedabad) | Generics, biogenerics, contract manufacturing | ||
Emcure–Gennova (Pune) | Biosimilars, Novel Vaccines | ||
Panacea Biotec (New Delhi) | Generics, vaccines | ||
Wockhardt (Mumbai) | Generics, biologics, vaccines | ||
Dr. Reddy’s Laboratories (Hyderabad) | Generics, vaccines, biosimilars, biologics | ||
GVK Biosciences (Hyderabad) | Generics, biogenerics | ||
Jubilant Biosys (Bengaluru) | Bioinformatics, contract research | ||
Academic scientist to bioentrepreneur | Bangalore Genei (Bengaluru) | Reagents supply, contract research | [21] |
Avesthagen (Bengaluru) | Plant biotech, diagnostics, nutraceuticals, contract research | ||
Strand Life Sciences (Bengaluru) | Bioinformatics | ||
Microtest Innovations (Bengaluru) | Diagnostics | ||
Industry professionals or academic scientists from overseas | Molecular Connections (Bengaluru); Cell | Bioinformatics, systems biology | [12,21] |
Bhat Biotech (Bengaluru) | Diagnostics | ||
Bharat Biotech International (Hyderabad) | Vaccines, Biosimilars | ||
Genotypic Technologies (Bengaluru) | Bioinformatics, contract research | ||
Connexios Life Sciences (Bengaluru) | Systems biology | ||
Ocium Biosolutions, Mapmygenome (Hyderabad) | Bioinformatics, Diagnostics | ||
Multinational company setting up in India | Quintiles India (Bengaluru); Accelrys (Bengaluru) | Bioinformatics, contract research | [21] |
Merck KGaA (Bengaluru); MWG (Bengaluru); Thermo-Fisher (Bengaluru); Sartorius (Bengaluru); DuPont (Hyderabad) | Reagents and equipment supply, customised bioservices; R&D facilities | ||
GlaxoSmithKline Pharmaceuticals Ltd., Mumbai | Generics, Vaccines | ||
Govt. initiated biotech company | Indian Immunologicals (Hyderabad); Human Biological Institute (Ooty) | Vaccines (Animal and Human) | - |
Bharat Immunological and Biologicals Corporation Limited (BIBCOL), (Bulandsahar, UP) | Vaccines | ||
Indian Vaccine Corporation Limited (Delhi) | |||
Start-up as emerging biotech company | Med Genome (Bengaluru), X Code Life (Chennai), FARCAST Biosciences (Bengaluru) | Bioinformatics, Diagnostics, drug dicovery | - |
BUGWORKS (Bengaluru) | Antimicrobials | ||
Pandorum (Bengaluru) | Tissue Engineering, Regenerative medicines | ||
Oncostem Diagnostics (Bengaluru) | Diagnostics and therapy | ||
Zumutor Biologics (Bengaluru) | Novel Immunotherapy and stem cell research. |
Industry | Country | Flagship Biosimilar | Market Share |
---|---|---|---|
Johnson and Johnson | USA | Remicade (Infliximab) [31] | 48.2% |
Pfizer | USA | Inflectra®®® (infliximab-dyyb in the US) [32] | |
Mylan | USA | Ogivri (Trastuzumab) [33] | |
Biogen | USA | Byooviz [34] | |
Eli Lilly | USA | Insulin Glargine [35] | |
Coherus Bioscience | USA | Cimerli (Ranibizumab-eqrn) [36,37,38] | |
MSD (Merck & Co) | Germany | Ontruzant (Trastuzumab) [39] | 18.1% |
Boehringer Ingelheim | Germany | Cyltezo (adalimumab-adbm) [40] | |
Fresenius Kabi AG | Germany | Stimufend [41] | |
StadaArzneimittel AG | Germany | Silapo (epoetin-zeta) [42] | |
mABxience | Switzerland | Novex (rituximab) [43] | |
Roche | Switzerland | Lucentis (ranibizumab) [44] | |
Sanofi Aventis | France | Lovenox (enoxaparin sodium) [45] | |
GlaxoSmithKline | British | Nucala (mepolizumab) [46] | |
Teva Pharmaceutical | Israel | Truxima (rituximab-abbs) [47] | |
Gan and Lee Pharmaceuticals | China | Glargine [48] | |
Amega Biotech | Argentina | Neutropine (Filgrastim) [49] | |
Samsung Biologics | South Korea | Byooviz [34] | |
Celltrion | South Korea | Remsima [50] | |
Chong Kun Dang | South Korea | Darbepoetin Alfa [51] | |
Probiomed | Mexico | Trastuzumab [52,53] | |
Apotex | Canada | Apobiologix (pegfilgrastim) [54] | |
JCR Pharmaceuticals | Japan | Agalsidase beta [55] | |
Gedeon Richter | Hungary | Terrosa [56] | |
Biocad | Russia | Trastuzumab [57] |
Product | Company Name | Active Drug Molecule | Therapeutic Use in |
---|---|---|---|
Glaritus | Wockhardt | Insulin Glargine | Diabetes |
Grafeel | Dr. Reddy’s Laboratories | Filgrastin | Neutropenia |
Pegfilgrastism | Lupin | Pegfilgrastin | Cancer, Neutropenia |
Epofer | Emcure | Epoetin alpha | Anemia |
Zyrop | Cadila Healthcare | Erythropeotin | Chronic kidney failure |
Krabeva | Biocon | Bevacizumab | Colorectal cancer |
Bevacirel | Reliance Life Sciences | ||
Cizumab | Hetero | ||
Erbitux | Cetuximab | Colorectal cancer | |
Acellbia | Biocad | Rituximab | NonHodgkin Lymphoma |
Maball | Hetero Group | ||
maTabs | Intas Pharmaceuticals | ||
Adafrar | Torrent Pharmaceuticals | Adalimumab | Rheumatoid Athritis, Crohn’s disease |
CaNMab | Biocon | Transtuzumab | Breast cancer |
Intacept | Intas Pharmaceuticals | Entanercept | Rheumatoid Athritis |
Relibeta | Reliance Life Sciences | Interferon Beta 1a | Multiple sclerosis |
Razumab | Intas Pharmaceuticals | Ranibizumab | Degenerative myopia |
AbcixiRel | Reliance Life Sciences | Abciximab | Angina, Cardiac ischemia |
Basalog | Biocon | insulin glargine | Diabetes |
Biovac-B | Wockhardt | hepatitis B vaccine | Hepatitis B |
FostiRel | Reliance Life Sciences | follitropin beta | Female infertility |
Mirel | Reliance Life Sciences | reteplase | Myocardial Infraction |
Zavinex | Cadila Health Care | Interferon alfa-2b | Chronic hepatitis B and C |
Choriorel | Reliance Life Sciences | chorionic gonadotrophin hormone r-hCG | Female infertility |
Sl. No. | Manufacturer | Licensed Vaccine | Target Species | Reference |
---|---|---|---|---|
1. | BCG Vaccine Laboratory, Guindy, Tamilnadu, India. | Tuberculine, BCG | Human | [63,64] |
2. | Pasteur Institute of India, Coonoor, The Nilgiris, Tamilnadu, India. | DTP, DT, TT and inactivated rabies vaccine | Humans and canine | [64,65,66] |
3. | Central Research Institute, Kasauli, Solan, Himachal Pradesh, India. | Yellow fever, JE, DTP, DT, TT | Humans | [64,67] |
4. | BIBCOL, Chola, Uttar Pradesh, India. | bOPV | Human | [64,68] |
5. | Haffkine, Parle, Mumbai, India. | bOPVand mOPV | Human | [68] |
6. | Human biological Institute, a division of Indian Immunologicals Limited, Hyderabad, Telangana, India. | Rabies, DTP, TT, DT, Hep- B, Pentavalent (DTP+Hib+HepB) | Human and canine | [64,68] |
7. | HLL Biotech Ltd., Taramani, Chennai, Tamil Nadu, India. | Hep B, DTwP- HepB-Hib | Human | [68] |
8. | Bharat biotech International Ltd., Hyderabad, Telangana, India. | Hib, Rabies, bOPV, mOPV, DTP+Hib+HepB, Vi polysaccharide Typhoid, H1N1, DTP, DTP+HepB, Rotavirus vaccine, Inactivated JE vaccine, Typhoid+TT Conjugate Vaccine andDTP+Hep- B+Hib (Liquid), DTP+Hib, BBV152 Covaxin | Human, canine | [64,68] |
9. | Biological E, Hyderabad, Andhra Pradesh, India. | DTP, TT, JE bulk & DT | Humans | [64,67] |
10. | Biomed Pvt. Ltd., Ghaziabad, Uttar Pradesh, India. | Hib, Meningococcal Polysaccharide, bOPV, Rabies, Meningococcal polysaccharide. | ||
11. | Cadila Healthcare, Ahmedabad, Gujarat, India. | Rabies, H1N1, trivalent influenza | Human | [64,68] |
12. | Serum Institute of India, Pune, Maharastra, India. | DTP, TT, DT, Hep-B, Hib, MMR, Measles, Rubella, BCG, IPV, DTP+HepB+Hib (Liquid+lyophilised), DTP+HepB, DTP+Hib, H1N1, Meningococcal A conjugate (lyophilised), Mumps, MR, H1N1(whole virion inactivated), Measles+Mumps, Measles+Rubela, Seasonal Influenza vaccine, COVID-19 vaccine | Human | [64,67,68] |
13. | Shantha Biotechnics Ltd., Hyderabad, India. | DTP, DTP+HepB+Hib (Liquid), DTP+Hib, DPT+Hep B, TT, Hib, Hep-B, DT bulk, TT Bulk, Hib Bulk, Hep B Bulk, DTP bulk, DTP+HepB+Hib bulk, DTP+HepB+Hib RTF bulk, Oral cholera vaccine, IPV RTF Bulk, IPV | Human | [64,67,68] |
Vaccines | Indian Manufacturer | Collaborator(s) | Current Regulatory Status |
---|---|---|---|
Covishield | Serum Institute of India, Pune, India | Oxford-AstraZeneca | Approved |
Covaxin | BharatBiotech Int. Ltd., Hyderabad, India | Indian Council of Medical Research, National Institute of Virology | Approved |
ZyCov-D | Cadila Healthcare Ltd., Ahmedabad, India | Department of Biotechnology, India | Approved |
Sputinik V | Dr. Reddy’s lab, Hyderabad, India | Gamaleya National Centre, Russia | Approved |
NCV-COV2373 | Serum Institute of India, Pune | Novovax | Emergency authorisation |
HGCO 19 m-RNA based vaccine | Genova, Pune, India | HDT-Bio, US DBT | Approved |
Recombinant protein-based Vaccine (Corbevax) | Biological E, Hyderabad, India | Baylor College, US | Approved |
Codon-deoptimised live attenuated COVID-19 Vaccine | Indian Immunologicals Limited, India | Griffith University, Australia | Pre-clinical |
Warm COVID-19 Vaccine | Mynvax, Indian institute of Science, Bengaluru, India | BIRAC |
Positively Contributing Factors | Negatively Affecting Factors | |
---|---|---|
Strengths (S) | Weaknesses (W) | |
Internal factors | 1. Young and aspiring workforce 2. Cost competitiveness 3. High efficacy, low cost and akin safety level; growing demand in healthcare 4. Affordable, low-cost biosimilars make medication cost-effective in a price-sensitive Indian market 5. Reduced cycle in synthesis and regulatory compliance compared to innovator molecule 6. Innovation, R&D focus in innovative therapeutics as key player at global scale 7. Government regulatory assistance to produce biosimilars 8. Government initiatives to foster confidence and encourage investment | 1. Poor Industry-Academia alliance 2. Low government funding to industry 3. Complex regulatory compliance process; lack of confidence in regulatory bodies and policy makers leading to high corporate cost in approval 4. Physicians not prescribing biosimilars; low awareness among the doctor and patient 5. Higher price compared to conventional generic drugs 6. Pharmacovigilance to monitor efficacy and safety needed for possible immunogenicity 7. Altered production process may alter biosimilars’ property 8. Batch-wise uniform production is a challenge; needs skilled manpower, and validated and verifiable SOP |
Opportunities (O) | Threats (T) | |
External factors | 1. Green-field, favourable emerging global biosimilars market 2. Fast-growing biopharma trade; US $300 million Indian biosimilar market anticipated to be worth US $40 billion by 2030 3. Over next few years, patent protection of many biologics expire 4. Vast prospect for cost-effective Indian biosimilars; biologics company start-ups booming 5. Biosimilar to cost 20–30% less than biologicals; low cost makes it affordable and accessible as demand grows 6. Government pledges to fund up to US $1.3 billion on API-based pharma business 7. Making APIs locally appear doable in next couple of years; to drive developing biotech-based medicines in India for the world 8. Efforts of DBT and BIRAC to support Indian biotech industry would benefit biologics industry 9. Government strategies focus on globally-acceptable legislation, entrepreneurship, industry-academia and public-private partnerships, and investment avenues for business house, investor and other agencies | 1. Stronger Chinese and Korean influence 2. Bargaining power of Indian companies with international patent litigations; patent litigation stifles smaller company from getting into biosimilars business 3. Lack of a comprehensive regulatory framework for biosimilars development 4. Tough approval process for pharama companies to enter global market 5. Delay in clinical trials approval, new pharma pricing policy, uniform code for sales and marketing practises, compulsory licencing, product quality, regularity uncertainty, reluctant to prescribe, and production complexity 6. Substantial competition from branded biologics than the tough competition as posed by small-molecule generics |
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Panda, S.; Singh, P.K.; Mishra, S.; Mitra, S.; Pattnaik, P.; Adhikary, S.D.; Mohapatra, R.K. Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics. Vaccines 2023, 11, 110. https://doi.org/10.3390/vaccines11010110
Panda S, Singh PK, Mishra S, Mitra S, Pattnaik P, Adhikary SD, Mohapatra RK. Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics. Vaccines. 2023; 11(1):110. https://doi.org/10.3390/vaccines11010110
Chicago/Turabian StylePanda, Sunita, Puneet Kumar Singh, Snehasish Mishra, Sagnik Mitra, Priyabrata Pattnaik, Sanjib Das Adhikary, and Ranjan K. Mohapatra. 2023. "Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics" Vaccines 11, no. 1: 110. https://doi.org/10.3390/vaccines11010110