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Biocon Biologics launches Hulio, a biosimilar for AbbVie’s Humira, in the U.S.

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Introduction

After five years of being used in Europe and two years in Canada, Biocon Biologics Ltd (BBL), a division of the Biocon Company Limited, recently stated that HULIO (adalimumab-flip) injectable, a biologic equivalent to Humira® (Adalimumab), is now accessible to patients in the United States.

The global biosimilar business of Viatris was recently acquired by Biocon Biologics, which has obtained many biosimilar clearances in the U.S., Europe, and more than 100 other nations. 

In the therapeutic areas of diabetes, cancer, and immunology, Biocon Biologics can now assist in supplying both patients and healthcare providers with more accessible and inexpensive treatment alternatives thanks to the acquisition of Viatris’ biosimilars company.

Biocon Biologics provides pharmacy benefit managers and health plans two options on the U.S. market. HULIO is offered at a list cost (wholesale acquisition cost) that is 5% less than the current list price for Humira. Additionally, Adalimumab is offered at a list price of almost 85% less than the present Humira list price.

HULIO: What is it?

Hulio is an immunosuppressive medication intended to treat the following conditions: plaque psoriasis, a disease of the skin that causes red, scaly patches; psoriatic arthritis, a condition that causes red, scaly skin patches and joint inflammation.

About Biocon

Bangalore-based Biocon Private Limited is a biopharmaceutical firm run by Indians. In 1978, Kiran Mazumdar-Shaw started it. The business produces counterfeit active pharmaceutical ingredients (APIs) distributed in about 120 nations, including the U.S. and Europe.

It also produces brand-name versions of biosimilar insulins, antibodies, and new biologics for sale in India. Biocon’s biosimilar pharmaceuticals are also offered in formulation and bulk forms in several emerging regions.

The Biocon Company’s history

The largest biotechnology business in Asia, Biocon, was founded in 1978 with just 10,000 rupees and is now worth $1 billion. The business produces biotechnology goods for the healthcare market. It participates in all stages of the product cycle, from drug discovery through development to commercialization. 

This pharmaceutical startup makes affordable medicines using fermentation-based technology. Biocon subsidiaries Syngene and Clinigene run R&D projects for large global pharmaceutical and biotechnology companies.

Biocon produces the anti-diabetic medications Acarbose, Pioglitazone, Repaglinide, and Rosiglitazone. Insulin, which is erythrocyte (EPO), filgrastim (GCSF), streptokinase, and monoclonal antibodies, are produced in the biological section. The large pharmaceutical company makes tacrolimus, sirolimus, and mycophenolate mofetil.

 Additionally, it produces and markets a variety of industrial and specialty enzymes for use in the paper, brewing, beverage, food, textile, and distilling industries. The company’s medicine line comprises Lovastatin, Simvastatin, Pravastatin, and Atorvastatin.

Subsidiaries

Biocon Biologics
Syngene International Ltd
Clinigene
BBPL
Biocon-AxiCorp
NeoBiocon
Biofusion Therapeutics Limited

Company operations

Biocon’s fully integrated business model covers the therapeutic value chain, from pre-clinical research to clinical development and commercialization. Its customized development (Syngene), clinical development (Clinigene), and biopharmaceuticals (Biocon) companies offer a variety of revenue streams that help to manage risk, stimulate innovation, produce goods, and speed up growth. 

The company thinks that the bespoke and customized services for clinical research will continue to offer significant synergies even as the complexity and breadth of its study and production processes rise, particularly in the area of novel product discovery and development.

Pre-Clinical Discovery is a synonym

Syngene, a specialized research division of Biocon, provides comprehensive and modular services for developing small and big molecules. We offer meticulous IPR protection and specialized solutions in biology, chemistry, process development and scale-up, creation, and logical growth, preliminary research offerings, and GMP manufacturing facilities for clinical supplies to the medicine, biological sciences, chemical, and agrochemical industries.

Clinical Research: Clinigene

A full-service clinical research organization, Clinigene International Limited is an innovative supplier of top-notch clinical research solutions to multinational pharmaceutical and biotechnology firms.

 Clinigene’s services cover a wide range of drug development activities, such as people pharmacology, bioanalytical research laboratories for both big and small molecules, central laboratories, clinical activities, healthcare written form, healthcare surveillance, safety oversight, and drug safety, clinical data management & biostatistics, and licensing services supporting early through late phase drug development.

Clinigene, a clinical study

Clinigene International Limited, a full-service clinical research company, is a cutting-edge provider of first-rate clinical research solutions to global pharmaceutical and biotechnology companies. 

Medical tasks, medical treatment documentation, medical care monitoring, oversight of safety and drug security, management of clinical data & biostatistics, and authorization services are just a few of the drug development activities covered by Clinigene’s services. 

Other drug development activities include human pharmacy, bioanalytical laboratory research involving big and small particles, crucial laboratories, clinical activities, and healthcare written form.

Biosimilar pharmaceuticals

The term “biosimilar” is a biological drug that is very similar to another biological drug that has already received approval (the “reference medicine”). The same pharmaceutical quality, safety, and efficacy standards used for other biological medicines determine whether or not to approve a biosimilar. 

The bulk of requests to commercialize biosimilars that are in the European Union (EU) are evaluated by the European Medicines Agency. 

Patients with chronic, frequently disabling illnesses like diabetes, autoimmune disease, and malignancies have access to therapy alternatives with biological therapies.

Modern technology is frequently used to produce biological medicines since they contain active ingredients derived from live cells or organisms (including humans, animals, and microorganisms like bacteria or yeast).

Conclusion

The Top 15 manufacturing businesses in the world include Biocon Biologics. Large-scale fermentation of microbes, synthesis of chemicals, mammal cell cultivation, proteins & antigen, the purification process, aseptic composition, and fill-finish are all included in the scope and breadth of its manufacturing capabilities.

Information By – Aayushi Bhanu

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