Hyderabad-based pharmaceutical major Aurobindo Pharma has indicated that its biosimilars segment is expected to become a significant growth driver for the company, with management identifying 2029 as a key milestone year for the business.

During the company’s recent quarterly earnings interaction, senior leadership said the organization is transitioning from the development stage into full-scale commercialization of biosimilar products across global markets. The company has already built a pipeline of multiple biologic and biosimilar therapies and plans to expand regulatory filings in major regulated markets including the United States and Europe.

Management believes these approvals, along with ongoing launches, will start contributing meaningfully to revenue toward the end of the decade. The company is aiming to establish broad coverage in the European region while also exploring growth opportunities in Latin America and other regulated geographies.

Expansion Across Global Markets

Aurobindo Pharma has been strengthening its presence in international markets through its biologics division. Some of its approved oncology biosimilar therapies are already available in select international markets, and additional products are under development and regulatory review. The company is also working with regional partners in certain countries to accelerate commercialization and improve market access.

In addition, regulatory inspections in countries such as Brazil are expected to open new pathways for approvals and product launches in the near future.

Building a Long-Term Biosimilars Portfolio

The company plans to build a diversified biosimilars portfolio over the next several years, with a long-term target of introducing around 15 products. Aurobindo believes the global regulatory environment is gradually becoming more supportive for biosimilars, which could help faster adoption and market expansion.

Industry initiatives in India supporting biologics manufacturing and research are also seen as positive developments. However, building domestic capabilities in clinical research and maintaining strict quality standards will be essential for global competitiveness.

Manufacturing and Penicillin Business Update

Alongside biologics, Aurobindo is also expanding utilization of its penicillin manufacturing facility in Andhra Pradesh. The company expects higher production levels over the next year and is working on cost-optimization measures to remain competitive with global suppliers. Government measures affecting imports of certain antibiotic intermediates are also expected to support domestic production.

Financial Performance

For the latest reported quarter, Aurobindo Pharma recorded steady growth in revenue along with improved margins. The European business showed strong expansion, while the US market posted moderate growth. The company continues to invest in research and development to support future product launches.

Management remains confident of achieving substantial European revenues in the current financial year and expects continued growth in the injectables segment in the United States.

Outlook

Aurobindo Pharma’s leadership believes that biosimilars will play a central role in the company’s long-term strategy. As commercialization expands and regulatory approvals increase, the business could become a major contributor to overall revenue by the end of the decade. The company is positioning itself to benefit from rising global demand for affordable biologic medicines, especially in oncology and specialty therapeutic areas.

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma, has announced positive results from a pivotal Phase 3 clinical study of its denosumab biosimilar, developed as an alternative to Prolia (denosumab) for treating postmenopausal osteoporosis.

The study, conducted across 40 sites in five European countries on 446 postmenopausal women, met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.

Dr Arpit Prajapati, Head of Clinical Sciences at CuraTeQ, said the trial evaluated the biosimilar’s efficacy in improving bone mineral density (BMD) and reducing fracture risk. The primary endpoint — percentage change in lumbar spine bone mineral density (LS-BMD) at Week 52 — achieved the pre-defined equivalence margin of (-1.45, +1.45). The co-primary endpoint, measuring the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) from Week 0 to Week 26, was within the regulatory range of (0.80, 1.25), satisfying criteria set by the US FDA and the European Medicines Agency (EMA).

Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ, said the company plans to begin regulatory submissions for the denosumab biosimilar in the EU, US, and other key regulated markets starting January 2026. The company has already held consultations with the FDA and is engaging with other regulators to facilitate a smooth review process.

About CuraTeQ: CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. The company is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: Trading View

Aurobindo Pharma Ltd’s wholly-owned step-down subsidiary, CuraTeQ Biologics, has received marketing authorisation from the European Commission for its trastuzumab biosimilar, Dazublys.

This regulatory milestone follows the positive opinion issued in April 2025 by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended Dazublys for approval based on its demonstrated similarity to the reference biologic, Herceptin.

Dazublys is indicated for the treatment of HER2-positive breast and gastric cancers, offering a more accessible therapeutic option in oncology care. The biosimilar has shown comparable quality, safety, and efficacy to the original trastuzumab product, supporting its use across EU member states.

Earlier in April 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dazublys, recommending its marketing authorization, according to a stock exchange filing.

This marks CuraTeQ’s third EMA-approved biosimilar in 2025, following the green light for Dyrupeg (pegylated filgrastim) in April and Zefylti (filgrastim) in February.

Additionally, Bevqolva, a bevacizumab biosimilar, was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in December 2024, bringing CuraTeQ’s total EU-region biosimilar approvals to four.

The approval of Dazublys reinforces Aurobindo Pharma’s strategic focus on expanding its biosimilars portfolio, particularly in the oncology and immunology segments, with a goal of launching at least 10 biosimilars by 2030.

About CuraTeQ: CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. The company is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: CNBC TV 18

CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys® (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells.

Commenting on the update, Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO Biologics, Vaccines, and Peptides stated “The CHMP’s positive opinion is based on demonstrating comprehensive analytical similarity and clinically no meaningful differences between Dazublys® and the reference biologic product Herceptin in terms of pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, and immunogenicity. Upon European Commission approval that is expected in July, Dazublys® will be available for use across EU member states. This marks our third biosimilar to receive CHMP’s endorsement and the fourth overall in the EU, alongside the approval of Bevqolva® (a bevacizumab biosimilar) by the MHRA in November 2024. Biosimilars are playing an important role in improving cancer care, and we remain committed to expanding our biosimilars portfolio to address the unmet needs of patients.”

Aurobindo Pharma’s Vice Chairman and Managing Director Mr. Nithyananda Reddy said, “The CHMP’s positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts inbuilding biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies.”

About CuraTeQ: CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. The company is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: Medical Dialogues

CuraTeQ Biologics, (a wholly owned subsidiary of Aurobindo Pharma) has announced successful Phase I study results for its new bone treatment medicine. The drug, BP16, is a biosimilar referencing Denosumab (Prolia).

The company tested the drug on 204 healthy volunteers, comparing it with Prolia — the original version sold in Europe and the United States.

The drug works by blocking a protein called RANKL, which is responsible for breaking down bone tissue. This makes it useful for treating:

• Bone thinning (osteoporosis) in women after menopause
• Bone problems caused by cancer metastasis
• Bone weakness from cancer treatments

The successful trial is a key step towards bringing this potentially more affordable version of the medicine to patients.

Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, said, “The results from our study confirmed that BP16 exhibits a PK profile nearly identical to the reference products, achieving key bioequivalence parameters — maximum serum concentration and area under the curve — within the established bioequivalence range of 80-125%.”

“Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product. The study, which included 204 subjects from Australia and New Zealand, successfully met all the predefined endpoints.”

Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics, said, “With the positive Phase 1 study results, we are optimistic about our ongoing Phase 3 study. This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025.”

About CuraTeQ: CuraTeQ Biologics Private Limited (CuraTeQ), a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. CuraTeQ’s vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars. It is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: CNBC TV 18

CuraTeQ Biologics, a step-down subsidiary of Aurobindo Pharma Limited, is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Dyrupeg (BP14, a pegylated filgrastim biosimilar) recommending the granting of a marketing authorisation. The CHMP positive opinion is expected to translate into a formal decision of approval by the European Commission in April 2025.

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Commenting on the update, Dr. Satakarni Makkapati, Director Aurobindo Pharma and CEO Biologics, Vaccines and Peptides said “After receiving the GMP certificate of compliance from the EMA in November, the positive opinion of Dyrupeg from CHMP follows the marketing approval of Bevqolva (a bevacizumab biosimilar) by UK’s MHRA in December 2024, and CHMP’s positive opinion of Zefylti (a filgrastim biosimilar) in December 2024. The CHMP positive opinion of Dyrupeg is based upon a review of evidence of analytical biosimilarity, demonstrating equivalence and no clinically meaningful differences in pharmacokinetics, pharmacodynamics, and immunogenicity to the EU-registered reference product Neulasta. We intend to bring these treatment options to patients in Europe in the second half of 2025 and are on course to file in additional markets for approval.”

Aurobindo Pharma’s Vice Chairman and Managing Director Mr. K. Nithyananda Reddy said, “The positive opinion received from CHMP for Dyrupeg furthers our commitment in developing high quality biosimilars and driving access to patients suffering from illnesses such as cancer. CuraTeQ has a broad pipeline of biosimilars across oncology and immunology segments and we are enthusiastic about the prospect of adding these over time to Aurobindo’s commercial portfolio in global markets.”

About CuraTeQ: CuraTeQ Biologics Private Limited (CuraTeQ), a subsidiary of Aurobindo Pharma Limited, is a global
biopharmaceutical company headquartered in Hyderabad, India. CuraTeQ’s vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars. It is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.