Biosimilars in India; current status and future perspectives

Meher, Bikash Ranjan; Balan, Sakthi; Mohanty, Rashmi Ranjan; Jena, Monalisa; Das, Smita

doi:10.4103/jpbs.jpbs_167_18

Cited by 25 publications

(20 citation statements)

References 13 publications

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“…The biologics, biosimilars, and bio-diagnostics developed by different biopharmaceuticals and biosimilar manufacturer to combat COVID-19, fall short to satisfy the global demand surpassing in-land need. Different countries are thus inclined to manufacturing their own diagnostics to satisfy national demand [26][27][28]. Late-entrant countries in biopharmaceutical industry, like Bangladesh, are now working towards developing their own biosimilar products, anticipating the forthcoming situations when these countries will have to lose access to World Trade Organisation (WTO) waiver as a consequence of leaving LDC category in 2024 [29][30][31][32][33].…”

Section: Discussionmentioning

confidence: 99%

Development and performance evaluation of a rapid in-house ELISA for retrospective serosurveillance of SARS-CoV-2

Sil

Jahan²,

Haq³

et al. 2021

PLoS ONE

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Background In the ongoing pandemic situation of COVID-19, serological tests can complement the molecular diagnostic methods, and can be one of the important tools of sero-surveillance and vaccine evaluation. Aim To develop and evaluate a rapid SARS-CoV-2 specific ELISA for detection of anti-SARS-CoV2 IgG from patients’ biological samples. Methods In order to develop this ELISA, three panels of samples (n = 184) have been used: panel 1 (n = 19) and panel 2 (n = 60) were collected from RT-PCR positive patients within 14 and after 14 days of onset of clinical symptoms, respectively; whereas panel 3 consisted of negative samples (n = 105) collected either from healthy donors or pre-pandemic dengue patients. As a capturing agent full-length SARS-CoV2 specific recombinant nucleocapsid was immobilized. Commercial SARS-CoV2 IgG kit based on chemiluminescent assay was used for the selection of samples and optimization of the assay. The threshold cut-off point, inter-assay and intra-assay variations were determined. Results The incubation/reaction time was set at a total of 30 minutes with the sensitivity of 84% (95% confidence interval, CI, 60.4%, 96.6%) and 98% (95% CI, 91.1%, 100.0%), for panel 1 and 2, respectively; with overall 94.9% sensitivity (95% CI 87.5%, 98.6%). Moreover, the clinical specificity was 97.1% (95% CI, 91.9%, 99.4%) with no cross reaction with dengue samples. The overall positive and negative predictive values are 96.2% (95% CI 89.2%, 99.2%) and 96.2% (95% CI, 90.6% 99.0%), respectively. In-house ELISA demonstrated 100% positive and negative percent agreement with Elecsys Anti-SARS-CoV-2, with Cohen’s kappa value of 1.00 (very strong agreement), while comparing 13 positive and 17 negative confirmed cases. Conclusion The assay is rapid and can be applied as one of the early and retrospective sero-monitoring tools in all over the affected areas.

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Section: Discussionmentioning

confidence: 99%

Development and performance evaluation of a rapid in-house ELISA for retrospective serosurveillance of SARS-CoV-2

Sil

Jahan²,

Haq³

et al. 2021

PLoS ONE

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“…Presently, there are more than 100 Indian biopharmaceutical companies, which are engaged in manufacturing and marketing of biosimilars. 2 A biosimilar can be used for all indications approved for the innovator drug and there is no need for independent clinical studies. However, the final decision rests with the regulators.…”

Section: Control Strategymentioning

confidence: 99%

“…Biosimilar applications are not permitted within 4 years of licensure of the reference product or Reference biologicals. 1,2 Studies conducted for approval of Biosimilar: Reference Biologic for study for purpose of approval in India for Similar Biologic…”

Section: Introductionmentioning

confidence: 99%

Biosimilar approval and checkpoints

Chaudhry

Dutta²

2021

JPMHH

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Biologic drugs and subsequently developed biosimilars treat chronic inflammatory autoimmune conditions such as rheumatoid or psoriatic arthritis, ankylosingspondylitis, crohn's disease, ulcerative colitis, and psoriasis. Biologics can target the cancer in a specific way and may work synergistically with chemotherapy to improve outcome. It is expected that in the next five years, 50% of biological products will originate from biotechnology. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the biologic drugs which are authorized for sale. The global market for Biosimilars is dominated by oncology (nearly 39% share) whereas the total biosimilar market size is expected to reach nearly 70 billion by 2025. Biosimilars are generally marketed at prices 25 to 40 percent below original branded productsie Biologics. The number of biosimilars approved by US FDA are nearly 30. There are about 25 top global manufacturers of biosimilars. Many Domestic companies in India are making strong presence even in regulated markets. (BPCIA) guidelines in the United States (US), mention that a biosimilar can be designated as “interchangeable”, whereby it may be substituted for the reference product (original biological drug).

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“…Adalimumab (Humira®, AbbVie Inc., USA) was first approved in December 2002 by the US Food and Drug Administration (FDA) and is currently approved for multiple immunemediated inflammatory diseases in addition to RA [15,16]. Biosimilar development has become imperative to improve patient's accessibility to bDMARDs with potentially low drug prices and resulting in reduction of treatment cost for healthcare systems and patients [17][18][19].…”

Section: Introductionmentioning

confidence: 99%

Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy

et al. 2020

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Background Our study aimed to compare efficacy and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy. Methods Patients (n = 168) were randomized (2:1) to receive either test or reference product for 24 weeks with concomitant MTX. Proportion of patients achieving American College of Rheumatology 20 (ACR20) criteria at week 12 was the primary endpoint. Changes in Disease Activity Score of 28 joints–C-reactive protein (DAS28-CRP), Health Assessment Questionnaire–Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24 were secondary endpoints. Results Patients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [− 6.0, 6.0], p = 1.000) for ACR20 at week 12 for ITT analysis showed lower limit of the two-sided 95% CI was above the pre-specified noninferiority margin of − 15%. Similar trend in PP analysis (PD [95% CI] 0.0 [− 0.03, 0.07], p = 1.000), confirmed therapeutic equivalence. No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p > 0.05). DAS28-CRP and HAQ-DI were similar between groups. Total of 54 patients reported 88 AEs during the study. Out of these, 60 AEs were reported in 34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab. Total two patients, one in each group reported two serious adverse events (Sinusitis and Viral infection) during the study and resolved completely. No deaths and no life threatening AEs were reported. Conclusion Results demonstrated Hetero’s adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy. Trial registration CTRI/2016/04/006884, Registered on 28/04/2016.

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Biosimilars in India; current status and future perspectives

Cited by 25 publications

References 13 publications

Development and performance evaluation of a rapid in-house ELISA for retrospective serosurveillance of SARS-CoV-2

Development and performance evaluation of a rapid in-house ELISA for retrospective serosurveillance of SARS-CoV-2

Biosimilar approval and checkpoints

Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy

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