Challand Biosimilar Consulting

The race for pharmaceutical companies to get their biosimilar products to market has intensified as patent expiry dates for a number of top-selling biological products have passed for many and for many others draw nearer. The regulatory pathways for the approval of biosimilars are well developed and tested globally. Many countries throughout the world have established legal and regulatory pathways which allow development of biosimilar products.  However, guidelines are not prescriptive and with significant advances in the scientific and analytical techniques e.g. in the field of physicochemical characterization combined with vast experience gained by the Regulatory Agencies over years of approving biosimilar products, the clinical requirements for any product is changing with time. Furthermore, biologic products are not identical, the quality and non-clinical packages for each product are different, and the commercial objectives of each client is different.

Challand Biosimilar Consulting is a company specializing in guiding pharmaceutical companies through the development and approval process of biosimilar products. The company operates in an environment where the race to bring biosimilars to market has intensified due to patent expiries of numerous top-selling biological products. Challand Biosimilar Consulting recognizes that while regulatory pathways for biosimilar approval are well-established globally, guidelines are not prescriptive. The company emphasizes that each client's needs are unique, and there is no one-size-fits-all approach. They focus on understanding individual client requirements to drive strategic regulatory and clinical plans. The company's expertise lies in navigating the complexities of biosimilar development, taking into account the latest advancements in scientific and analytical techniques, particularly in physicochemical characterization. Challand Biosimilar Consulting acknowledges that the clinical requirements for biosimilar products are evolving, influenced by the extensive experience gained by regulatory agencies over years of approving these products.

Challand Biosimilar Consulting in United Kingdom

Rodeina Challand • BioTech Pharma Summit

Bringing Life-Saving Biologics to More Patients

Biosimilars

Challand Biosimilar Consulting is a company specializing in guiding pharmaceutical companies through the development and approval process of biosimilar products. The company operates in an environment where the race to bring biosimilars to market has intensified due to patent expiries of numerous top-selling biological products. Challand Biosimilar Consulting recognizes that while regulatory pathways for biosimilar approval are well-established globally, guidelines are not prescriptive. The company emphasizes that each client's needs are unique, and there is no one-size-fits-all approach. They focus on understanding individual client requirements to drive strategic regulatory and clinical plans. The company's expertise lies in navigating the complexities of biosimilar development, taking into account the latest advancements in scientific and analytical techniques, particularly in physicochemical characterization. Challand Biosimilar Consulting acknowledges that the clinical requirements for biosimilar products are evolving, influenced by the extensive experience gained by regulatory agencies over years of approving these products.
Key customers and partnerships
Challand Biosimilar Consulting works with a range of clients in the pharmaceutical industry, from startups to large biotech and pharmaceutical companies. The company has experience in collaborating with regulatory agencies across various regions, including Europe, the US, Japan, Australia, Singapore, and South Korea. Their services have been utilized in the development of over 12 biosimilar molecules across various products and indications, including ESAs, Filgrastims, Heparins, Insulins, orphan drugs, and monoclonal antibodies.

Coherus BioSciences is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative immunotherapies for cancer treatment. The company's strategy revolves around building a leading immuno-oncology franchise funded by cash generated from its portfolio of FDA-approved therapeutics. Coherus markets several biosimilar products in the US, including UDENYCA (pegfilgrastim-cbqv), a biosimilar of Neulasta, CIMERLI (ranibizumab-eqrn), a biosimilar of Lucentis, and YUSIMRY (adalimumab-aqvh), a biosimilar of Humira.
In July 2023, Coherus launched YUSIMRY at a list price of USD 995 per carton for two 40 mg/0.8 mL autoinjectors, representing a discount of more than 85% compared to Humira. This pricing strategy aims to improve patient access to adalimumab treatment by offering significant cost savings. YUSIMRY is indicated for various autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, and Crohn's disease.
Coherus is also developing toripalimab, an anti-PD-1 antibody, for the US and Canadian markets through a licensing agreement with Shanghai Junshi Biosciences Ltd. A Biologics License Application (BLA) for toripalimab in combination with chemotherapy for treating recurrent or metastatic nasopharyngeal carcinoma was under FDA review.
In March 2024, Coherus reported net revenue of USD 91.5 million for Q4 2023 and USD 257.2 million for the full year 2023, driven by sales of UDENYCA and CIMERLI. However, the company faced challenges, including a net loss of USD 79.7 million in Q4 and USD 237.9 million for the full year 2023. To address these challenges, Coherus initiated a workforce reduction of 30% to streamline operations and focus on oncology.

Coherus Biosciences

Custom Biologics is a Canadian contract research organization (CRO) specializing in bioanalytical services for biopharmaceuticals, vaccines, and cell and gene therapy products. With over 20 years of experience, the company focuses on designing and validating regulatory compliant assays for functional characterization, potency/bioactivity assessments, clinical pharmacokinetics, and immunogenicity of biotherapeutic drugs. Custom Biologics' genomics group develops molecular genetic assays for gene and genome analysis, measuring genetic inserts and transgenes in gene therapy vectors, oncolytic viruses, and nucleic acid-based vaccines. The company has also developed a proprietary isothermal nucleic acid amplification technology called DASL-RAPID for rapid identification of human and food-borne pathogens. Custom Biologics maintains a Health Canada cGMP Drug Establishment License and operates under a quality system based on FDA and EMEA GLP guidelines. The company's services are utilized in preclinical research and development programs, as well as for validated GMP-compliant assays suitable for stability analysis, clinical analysis, and clinical/market lot release testing. Custom Biologics employs state-of-the-art bioanalytical laboratory equipment and sophisticated statistical software to generate data for submissions to regulatory agencies worldwide.

Custom Biologics

CuriRx, Inc., founded in 2012, is a contract development and manufacturing organization (CDMO) based in Wilmington, Massachusetts. The company specializes in providing end-to-end support for biotherapeutic drug developers, focusing on complex molecules such as recombinant proteins, monoclonal antibodies, bispecific antibodies, vaccines, antibody drug conjugates, oligonucleotides, and gene therapy products. CuriRx's services encompass upstream and downstream process development, optimization, characterization, scale-up and scale-down, analytical development, formulation development, and lyophilization.
In January 2022, CuriRx launched its Advanced Bioprocessing and Analytical Center, which combines state-of-the-art bioprocessing laboratories with the CuriLytics Platform's high-resolution analytical instrumentation. This center aims to accelerate biotherapeutic drug development by leveraging the team's extensive bioprocessing experience and employing the latest methods in upstream and downstream process development. The CuriLytics Platform utilizes high-resolution mass spectrometry and various orthogonal characterization methods to further de-risk drug development.
CuriRx has the capacity to produce non-GMP vials for animal studies and non-GMP stability support studies. The company's key personnel have been involved in successful development projects for notable drugs such as HUMIRA, SYNAGIS, BLINCYTO, and GATTEX. In September 2013, CuriRx was awarded a five-year contract by the National Cancer Institute for the development and production of oncology products, demonstrating its expertise in the field.

CuriRx

Paras Biopharmaceuticals Finland Oy is a biopharmaceutical technology development company based in Oulu, Finland. Founded in 2012, the company specializes in the development and manufacturing of complex biologics and biosimilars using microbial expression systems. Paras Biopharmaceuticals operates a state-of-the-art 25,000 square foot biologics production facility in Finland, which includes 4,300 square feet of classified cleanroom space. The facility is equipped for media and buffer preparation, fermentation, harvest and extraction, purification, final filtration, and freeze-drying.
The company's core activities are divided into two main divisions: Paras Biopharma, which focuses on biologics Contract Development and Manufacturing Organization (CDMO) services, and Paras Biologics, which handles biosimilar development and licensing. Paras Biopharmaceuticals has developed proprietary technology platforms including Biomultifold, Noblecleav, and Cytofold StructQuant to achieve high productivity and quality in biologics manufacturing. These technologies enable the company to produce complex proteins and biosimilars cost-effectively at scale.
As of December 2022, Paras Biopharmaceuticals reported achieving success with "Continuous Biomanufacturing" for high-value onco-immunology and urology biosimilars. The company has also made advancements in maximizing recombinant protein expression in microbial systems, reporting expression levels of up to 12g/L or more of fully folded, biologically active protein in fermentation broth as of July 2023.

Paras Biopharmaceuticals

Kashiv Biosciences, LLC is a fully integrated biopharmaceutical company focused on developing biosimilars and specialty biopharmaceutical products. The company has global research and development, clinical, regulatory, and manufacturing capabilities. Kashiv utilizes its MayaBio reactor technology to develop biosimilars. The company's product portfolio includes biosimilars targeting conditions such as asthma, chronic idiopathic urticaria, and neutropenia. Kashiv's lead biosimilar candidate, ADL018, is a proposed biosimilar to Xolair (omalizumab) currently in Phase III clinical trials for chronic spontaneous urticaria. In March 2022, Kashiv received FDA approval for its first biosimilar RELEUKO (filgrastim-ayow), a biosimilar referencing Neupogen. The company has a robust pipeline of seven biosimilars and multiple 505(b)(2) and complex peptide generic products in development. Kashiv operates FDA-approved GMP manufacturing facilities in Chicago, Illinois and has state-of-the-art R&D infrastructure in Ahmedabad, India. The company is headquartered in Piscataway, New Jersey.
Key customers and partnerships
Kashiv has established strategic partnerships to commercialize its products globally. In October 2023, Kashiv entered into an exclusive licensing agreement with Alvotech for the development and commercialization of ADL018 in Europe, the UK, Australia, Canada, and New Zealand. In July 2024, Kashiv signed an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of ADL018 in the US. Kashiv has also collaborated with Amneal on the development and commercialization of other biosimilars, including RELEUKO and FYLNETRA. These partnerships allow Kashiv to leverage its partners' commercial expertise and global reach to bring its biosimilar products to market.

Kashiv Biosciences

Biotechnology companies that focus on the research, development, production, and commercialization of prescription drugs including biosimilars.

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Companies offering R&D capabilities and production facilities to biosimilar companies on contracts or partnerships.

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Companies offering testing solutions to support the biological characterization, comparability, and other clinical assessments required in the biosimilar development process.

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Challand Biosimilar Consulting

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