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Breaking News: Biocon Biologics Launches Biosimilar of Humira in the United States 2023

Breaking News: Biocon Biologics Launches Biosimilar of Humira in the United States 2023

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

Biocon Biologics, a leading global biopharmaceutical company, has made a significant breakthrough in biosimilars with the launch of its highly anticipated biosimilar of Humira in the United States. Humira, an adalimumab-based drug, is widely recognized as one of the world’s best-selling pharmaceutical products. The availability of Biocon Biologics’ biosimilar in the U.S. market represents a milestone in the company’s commitment to expanding patient access to high-quality, affordable biologic therapies.

India's Biocon Biologics launches biosimilar for AbbVie's Humira in US |  Reuters

After five years of use in Europe and two years in Canada, Biocon Biologics Ltd (BBL), a Biocon Ltd. subsidiary, said on Tuesday that HULIO (adalimumab-flip) injectable, a biosimilar of Humira (adalimumab), is now accessible to patients in the United States.

The company’s press release claims that Biocon Biologics, which recently announced its acquisition of Viatris’ international biosimilars business, has obtained several biosimilar approvals in the U.S., Europe, and more than 100 other nations worldwide.

Biosimilars are biological products highly similar to reference natural drugs, commonly called originators or reference products. They offer comparable safety, efficacy, and quality and are developed as affordable alternatives to the original products. Biosimilars are crucial in improving patient access to life-saving treatments by providing more affordable options while maintaining the same therapeutic benefits.

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Biocon Biologics, a subsidiary of Biocon Ltd., has become a world leader in creating and producing biosimilars. With a strong focus on research and development, the company has built a robust portfolio of biosimilars that spans multiple therapeutic areas, including oncology, immunology, and chronic diseases. Biocon Biologics has established strategic partnerships and collaborations with leading global pharmaceutical companies, allowing complete access to its biosimilars across various geographies.

“The introduction of HULIO, our biosimilar adalimumab, in the United States is a significant turning point for Biocon Biologics as it broadens the range of patients we can provide our well-known biosimilar products. The company’s CEO and managing director, Shreehas Tambe, said this launch “builds on our strong presence in oncology and diabetes and re-affirms our commitment to enabling affordable access to biologics.”

Biocon Biologics, Viatris receive EC approval for biosimilar insulin as  part Kixelle, ET HealthWorld

The launch of Biocon Biologics’ biosimilar of Humira in the United States is a significant achievement, considering the stringent regulatory landscape for biosimilars in the country. The FDA in the U.S. has a vital responsibility to ensure the safety and effectiveness of biosimilars before they are accessible to patients. Biocon Biologics successfully obtained FDA approval after an extensive evaluation process, which included comprehensive analytical, non-clinical, and clinical studies to establish the biosimilar’s similarity to the reference product.

The availability of Biocon Biologics’ biosimilar of Humira in the United States brings several notable advantages. This is important for patients, healthcare providers, and the entire healthcare system. This is important for patients, healthcare providers, and healthcare as the whole system.

  1. Increased Patient Access: Introducing a biosimilar alternative to Humira expands patient access to a proven and effective therapy, particularly for those who may have faced challenges due to the high cost of the reference product. Improved affordability can significantly enhance patients’ adherence to their prescribed treatment regimens.
  2. Cost Savings: Biosimilars have the potential to generate substantial cost savings for patients, healthcare providers, and payers. The availability of Biocon Biologics’ biosimilar offers a more affordable treatment option while maintaining comparable safety and efficacy to the reference product, potentially alleviating the financial burden associated with chronic conditions.
  3. Competition and Market Dynamics: The entry of Biocon Biologics‘ biosimilar fosters healthy competition in the market, promoting price transparency and encouraging innovation in biologic therapies. Increased competition can drive down prices, benefitting both patients and the healthcare system in the long run.
  4. Quality and Safety: Biocon Biologics’ biosimilar has undergone rigorous testing and regulatory scrutiny to ensure its safety, efficacy, and quality. It meets the same stringent standards as the reference product, providing patients with a reliable treatment option.

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Biocon Biologics asserted that with the acquisition of Viatris’ biosimilars division, it can now assist in supplying patients and medical professionals with more readily available and reasonably priced therapy alternatives in immunology, cancer, and diabetes.

“Biocon Biologics is happy to introduce HULIO, a patient-friendly, 2-click, prefilled pen for patients with certain inflammatory illnesses, in the United States. No buttons need to be pushed. Patients remove the cap and press the device against their skin to start their injection. Healthcare professionals and patients don’t have to lose a beat with HULIO since it was created with patients in mind; they “Click, Click, Go,” according to Mathew Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd.

Biocon Biologics gets European Medicines Agency's backing for Inpremzia |  The Financial Express

Biocon Biologics’ biosimilar of Humira becoming available in the United States represents a significant milestone in biosimilars. By expanding patient access to an affordable alternative, this achievement contributes to improving healthcare outcomes, reducing costs, and promoting innovation. As Biocon Biologics continues to demonstrate its commitment to advancing affordable biologic therapies, the availability of its biosimilar of Humira marks an unprecedented step toward transforming healthcare and making life-saving treatments more accessible to patients across the United States.



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