Aurobindo Pharma Ltd. on Friday (December 13) announced that its wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Zefylti (BP13), a Filgrastim biosimilar.

“…the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Zefylti (BP13, a filgrastim biosimilar) recommending the granting of a marketing authorisation to CuraTeQ Biologics Private Limited, a wholly-owned subsidiary of the company,” Aurobindo Pharma said in a regulatory filing.

The CHMP recommendation is a critical step towards obtaining marketing authorisation for Zefylti in the European Union. Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs).

Aurobindo Pharma spokesperson said, “After receiving the GMP certificate of compliance from the European Medicines Agency (EMA) in November, Zefylti is our first biosimilar to receive a positive opinion from EMA’s CHMP. Two more products, our biosimilar versions of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA, and a biosimilar to bevacizumab (BP01) is under review with the MHRA. We are confident and on track to bring these treatment options to patients next year.”

Article excerpt reposted from CNBCTV18.

Aurobindo Pharma Limited on Tuesday announced that its wholly owned subsidiary CuraTeQ Biologics Private Limited has received a GMP certificate of compliance for its biosimilars manufacturing facility from the EMA.

According to the company’s statement, the GMP inspection, conducted by EMA representatives from April 8th to April 12th, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and release laboratories.

“The EU GMP certification marks a significant milestone in CuraTeQ’s commitment to manufacturing high-quality biosimilars for patients worldwide. This inspection outcome paves way for securing approvals for our three biosimilars in Europe, currently under review by the Agency, within the next two to five months,” Dr. Satakarni Makkapati, Director of Aurobindo Pharma Limited and CEO of Biologics, Vaccines, and Peptides, said.

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.

“Our portfolio comprises fourteen biosimilars in development across oncology and immunology segments. We are dedicated to building a sustainable biosimilars portfolio and bringing these essential therapies to patients,” K. Nithyananda Reddy, Vice-Chairman and Managing Director of Aurobindo Pharma Limited, said.

The company has has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products, it added.

Article reposted from Financial Express.

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, announced that their Omalizumab biosimilar candidate BP11 has met the Phase 1 trial end points vis-à-vis the EU and US sourced reference product Xolair. The PK/PD trial was conducted in 165 healthy volunteers in Australia and New Zealand.

“The primary objective was to prove pharmacokinetic (PK) equivalence between BP11, US and EU sourced Xolair. 165 healthy volunteers were randomized to receive either BP11 or EU or US licensed Omalizumab via subcutaneous route of administration. Results of both primary parameters, i.e. maximum serum concentration (Cmax) and area under concentration-time curve from time zero to infinity (AUC0-inf), were contained within 80-125% bioequivalence limit demonstrating PK equivalence between BP11 and both US and EU sourced Xolair. BP11 also had similar IgE levels to Xolair demonstrating comparable pharmacodynamic profile versus US and EU sourced Xolair. The safety and immunogenicity profiles were also found comparable versus the originator’s product,” said Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ Biologics.

Dr. Disha Dadke, Associate President and Head R&D, said, “We have initiated a Phase 3 study of our Omalizumab candidate BP11 for the treatment of chronic spontaneous or idiopathic urticaria, which is a presence of hives that are itchy and can last for a number of weeks with no apparent external trigger. The Phase 3 efficacy and safety study is being conducted across multiple sites in seven European countries and in 600 patients with chronic spontaneous urticaria. Additionally, a separate Phase 3 trial in asthma patients is being carried out in the Indian population. CuraTeQ intends to file the Omalizumab biosimilar product in India in 2024 and is on track to file the product in regulated markets in 2025.”

About CuraTeQ: CuraTeQ Biologics (a wholly owned subsidiary of Aurobindo Pharma Ltd.) is a biopharmaceutical company based out of Hyderabad, India. Our vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars. CuraTeQ has a development pipeline of 14 biosimilars, of which, three products have been filed with EMA, one product has been filed with MHRA, and four more products are in global phase 3 clinical trials.

For more information, write to us at info@curateqbio.com

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, announced that their Omalizumab biosimilar candidate BP11 has met the Phase 1 trial end points vis-à-vis the EU and US sourced reference product Xolair. The PK/PD trial was conducted in 165 healthy volunteers in Australia and New Zealand.

“The primary objective was to prove pharmacokinetic (PK) equivalence between BP11, US and EU sourced Xolair. 165 healthy volunteers were randomized to receive either BP11 or EU or US licensed Omalizumab via subcutaneous route of administration. Results of both primary parameters, i.e. maximum serum concentration (Cmax) and area under concentration-time curve from time zero to infinity (AUC0-inf), were contained within 80-125% bioequivalence limit demonstrating PK equivalence between BP11 and both US and EU sourced Xolair. BP11 also had similar IgE levels to Xolair demonstrating comparable pharmacodynamic profile versus US and EU sourced Xolair. The safety and immunogenicity profiles were also found comparable versus the originator’s product,” said Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ Biologics.

Dr. Disha Dadke, Associate President and Head R&D, said, “We have initiated a Phase 3 study of our Omalizumab candidate BP11 for the treatment of chronic spontaneous or idiopathic urticaria, which is a presence of hives that are itchy and can last for a number of weeks with no apparent external trigger. The Phase 3 efficacy and safety study is being conducted across multiple sites in seven European countries and in 600 patients with chronic spontaneous urticaria. Additionally, a separate Phase 3 trial in asthma patients is being carried out in the Indian population. CuraTeQ intends to file the Omalizumab biosimilar product in India in 2024 and is on track to file the product in regulated markets in 2025.”

About CuraTeQ: CuraTeQ Biologics (a wholly owned subsidiary of Aurobindo Pharma Ltd.) is a biopharmaceutical company based out of Hyderabad, India. Our vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars. CuraTeQ has a development pipeline of 14 biosimilars, of which, three products have been filed with EMA, one product has been filed with MHRA, and four more products are in global phase 3 clinical trials.

For more information, write to us at info@curateqbio.com

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, announced that their Omalizumab biosimilar candidate BP11 has met the Phase 1 trial end points vis-à-vis the EU and US sourced reference product Xolair. The PK/PD trial was conducted in 165 healthy volunteers in Australia and New Zealand.

“The primary objective was to prove pharmacokinetic (PK) equivalence between BP11, US and EU sourced Xolair. 165 healthy volunteers were randomized to receive either BP11 or EU or US licensed Omalizumab via subcutaneous route of administration. Results of both primary parameters, i.e. maximum serum concentration (Cmax) and area under concentration-time curve from time zero to infinity (AUC0-inf), were contained within 80-125% bioequivalence limit demonstrating PK equivalence between BP11 and both US and EU sourced Xolair. BP11 also had similar IgE levels to Xolair demonstrating comparable pharmacodynamic profile versus US and EU sourced Xolair. The safety and immunogenicity profiles were also found comparable versus the originator’s product,” said Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ Biologics.

Dr. Disha Dadke, Associate President and Head R&D, said, “We have initiated a Phase 3 study of our Omalizumab candidate BP11 for the treatment of chronic spontaneous or idiopathic urticaria, which is a presence of hives that are itchy and can last for a number of weeks with no apparent external trigger. The Phase 3 efficacy and safety study is being conducted across multiple sites in seven European countries and in 600 patients with chronic spontaneous urticaria. Additionally, a separate Phase 3 trial in asthma patients is being carried out in the Indian population. CuraTeQ intends to file the Omalizumab biosimilar product in India in 2024 and is on track to file the product in regulated markets in 2025.”

About CuraTeQ: CuraTeQ Biologics (a wholly owned subsidiary of Aurobindo Pharma Ltd.) is a biopharmaceutical company based out of Hyderabad, India. Our vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars. CuraTeQ has a development pipeline of 14 biosimilars, of which, three products have been filed with EMA, one product has been filed with MHRA, and four more products are in global phase 3 clinical trials.

For more information, write to us at info@curateqbio.com

Aurobindo Pharma on Tuesday said its subsidiary CuraTeQ Biologics has expanded the scope of its marketing and distribution agreement with Orion Corporation (Orion).

Aurobindo Pharma on Tuesday said its subsidiary CuraTeQ Biologics has expanded the scope of its marketing and distribution agreement with Orion Corporation (Orion) to commercialise its biosimilars pipeline to include the Baltic states in Europe.

Under the terms of the agreement, Orion will be responsible for commercialisation of CuraTeQ’s biosimilar products, currently in various stages of development/filing for the partnered territories, Aurobindo Pharma said in regulatory filing.

CuraTeQ filed its first oncology biosimilar product with the European Medicines Agency (EMA) in September 2021 and filed its second biosimilar product, also in the oncology segment on January 10, 2022.

“We remain committed to expand the reach of our affordable, high quality products to patients globally and the strengthening of partnership with Orion provides our biosimilar products a pan-Europe access. We are encouraged with our progress on biosimilars development and look forward to execution of the same in the coming years,” Aurobindo Pharma Vice Chairman & Managing Director Nithyananda Reddy stated.

CuraTeQ CEO Satakarni Makkapati said Orion has a demonstrated and proven track record of successfully commercialising biosimilars in the Nordic and Baltic states in Europe.

“Orion’s understanding of the biosimilars adoption along with extensive commercial infrastructure in the NORDICS and other territories in the EEA make it an ideal partner to expand the accessibility of our biosimilar products in selected markets of Europe, complementing our group’s wide footprint in other European markets, he stated.

Orion Corporation SVP Specialty Products Virve Laitinen said the agreement will strengthen the company’s position as one of the leading generics providers in the Nordics and Baltics.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Article reposted from Business Standard