# Biosimilars * **Definition:** Biological products that are highly similar to an already approved reference product, with no clinically meaningful differences in terms of safety, purity, and potency, intended to provide similar efficacy and safety in treatment. * **Taxonomy:** Healthcare Topics / Biosimilars ## News * Selected news on the topic of **Biosimilars**, for healthcare technology leaders * 4K news items are in the system for this topic * Posts have been filtered for tech and healthcare-related keywords | Date | Title | Source | | --- | --- | --- | | 5/18/2025 | [**Affordability Gap: How Automation is Advancing Biosimilar Adoption - HIT Consultant**](https://hitconsultant.net/2025/05/19/affordability-gap-how-automation-is-advancing-biosimilar-adoption/) | [[HIT Consultant]] | | 5/14/2025 | [**Europe Biosimilars Market Analysis, Growth Trends, and Forecasts 2025-2032**](https://finance.yahoo.com/news/europe-biosimilars-market-analysis-growth-114500046.html) | [[Yahoo Finance]] | | 5/14/2025 | [**Bevacizumab Biosimilar Market Insights Report 2025: A Paradigm Shift in Oncology with ...**](https://finance.yahoo.com/news/bevacizumab-biosimilar-market-insights-report-151800174.html) | [[Yahoo Finance]] | | 4/29/2025 | [**Evolving Treatment Landscape in nAMD, DME Reduces Patient Burden, Improves Outcomes: Casey Koch, PharmD**](https://www.ajmc.com/view/evolving-treatment-landscape-in-namd-dme-reduces-patient-burden-improves-outcomes-casey-koch-pharmd) | [[AJMC]] | | 3/14/2025 | [**As Biosimilar Substitutions Become More Common, Education and Patient Counseling Are Paramount**](https://www.pharmacytimes.com/view/as-biosimilar-substitutions-become-more-common-education-and-patient-counseling-are-paramount) | [[Pharmacy Times]] | | 2/28/2025 | [**US Biosimilars Surge Clinical Trials Regulatory Shifts And The Path To Dominance**](https://www.clinicalleader.com/doc/u-s-biosimilars-surge-clinical-trials-regulatory-shifts-and-the-path-to-dominance-0001) | [[Clinical Leader]] | | 2/24/2025 | [**Updates on the Use of Biosimilars for Pediatric Patients with Rheumatic Disease**](https://www.pharmacytimes.com/view/updates-on-the-use-of-biosimilars-for-pediatric-patients-with-rheumatic-disease) | [[Pharmacy Times]] | | 2/10/2025 | [**Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars**](http://www.clinicalleader.com/doc/clinical-regulatory-changes-one-of-many-tailwinds-for-biosimilars-0001) | [[Clinical Leader]] | | 2/10/2025 | [**Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars**](https://www.clinicalleader.com/doc/clinical-regulatory-changes-one-of-many-tailwinds-for-biosimilars-0001) | [[Clinical Leader]] | | 2/10/2025 | [**Biosimilars Market Size to Hit USD 127.92 Billion by 2032, Growing at a 17.7AGR - SNS Insider**](https://finance.yahoo.com/news/biosimilars-market-size-hit-usd-130000868.html) | [[Yahoo Finance]] | | 1/23/2025 | [**Biosimilar Market Share: Growth and Price Trends in Q1 2025**](https://www.ajmc.com/view/biosimilar-market-share-growth-and-price-trends-in-q1-2025) | [[AJMC]] | | 1/14/2025 | [**Integrating Biosimilars Into Retina and Neurology Practices Requires Careful Planning**](https://www.pharmacytimes.com/view/integrating-biosimilars-into-retina-and-neurology-practices-requires-careful-planning) | [[Pharmacy Times]] | | 12/30/2024 | [**5 MedTech Stocks That Are Poised to Beat the Market in 2025 - Yahoo Finance**](https://finance.yahoo.com/news/5-medtech-stocks-poised-beat-140000672.html) | [[Yahoo Finance]] | | 12/12/2024 | [**ASHP Midyear: Pharmacists Play Key Role in Addressing Concerns and Fostering Adoption of Biosimilars**](https://www.pharmacytimes.com/view/ashp-midyear-pharmacists-play-key-role-in-addressing-concerns-and-fostering-adoption-of-biosimilars) | [[Pharmacy Times]] | | 12/4/2024 | [**Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars**](https://www.ajmc.com/view/policy-proposals-aim-to-stimulate-the-long-term-sustainability-of-infused-biosimilars) | [[AJMC]] | | 11/15/2024 | [**Biosimilars Market to grow by USD 54.35 billion (2024-2028), cost advantage over biologics to drive revenue, Report with the AI impact on market trends - Technavio**](https://www.prnewswire.com/news-releases/biosimilars-market-to-grow-by-usd-54-35-billion-2024-2028-cost-advantage-over-biologics-to-drive-revenue-report-with-the-ai-impact-on-market-trends---technavio-302306608.html) | [[PR Newswire]] | | 11/8/2024 | [**Biosimilars Market Industry Report 2024 - Rising Demand for Biosimilars as a Cost-effective ...**](https://finance.yahoo.com/news/biosimilars-market-industry-report-2024-093700264.html) | [[Yahoo Finance]] | | 11/5/2024 | [**Removing Need for Switching Studies Could Change Payer Perspectives of Biosimilars**](https://www.ajmc.com/view/removing-need-for-switching-studies-could-change-payer-perspectives-of-biosimilars) | [[AJMC]] | | 11/4/2024 | [**Biosimilars Are Making Inroads In U.S., But It's Still A Bumpy Ride**](https://www.forbes.com/sites/joshuacohen/2024/11/04/biosimilars-are-making-inroads-in-us-but-its-still-a-bumpy-ride/) | [[Forbes]] | | 11/2/2024 | [**The Top 5 Hurdles Facing the Biosimilars Market Right Now**](https://www.beckershospitalreview.com/pharmacy/the-top-5-hurdles-facing-the-biosimilars-market-right-now?utm_campaign=bhr&utm_source=website&utm_content=related) | [[Beckers Hospital Review]] | | 11/1/2024 | [**The Top 5 Hurdles Facing the Biosimilars Market Right Now**](https://www.beckershospitalreview.com/pharmacy/the-top-5-hurdles-facing-the-biosimilars-market-right-now.html) | [[Beckers Hospital Review]] | | 10/28/2024 | [**Biosimilars Expand Access and Reduce Costs in Oncology, Immunology**](https://www.ajmc.com/view/biosimilars-expand-access-and-reduce-costs-in-oncology-immunology) | [[AJMC]] | | 10/15/2024 | [**Samsung Bioepis Reports 2024 Biosimilar Market Growth Trends**](https://www.ajmc.com/view/samsung-bioepis-reports-2024-biosimilar-market-growth-trends) | [[AJMC]] | | 9/27/2024 | [**Report Highlights Biosimilars Savings, but High Out-of-Pocket Costs for Patients**](https://www.ajmc.com/view/report-highlights-biosimilars-savings-but-high-out-of-pocket-costs-for-patients) | [[AJMC]] | | 9/4/2024 | [**Drug Survival of Biosimilars, Originator TNF Inhibitors Similar**](https://www.ajmc.com/view/drug-survival-of-biosimilars-originator-tnf-inhibitors-similar) | [[AJMC]] | ## Topic Overview (Some LLM-derived content — please confirm with above primary sources) ### Key Players - **Biocon Biologics**: A global biosimilars organization committed to providing affordable access to high-quality biosimilars. - **Biocon Biologics Ltd**: A global biosimilars company focused on providing affordable access to high-quality biosimilars, with a pipeline of 12 biosimilar assets under development. - **Samsung Bioepis**: A significant player in the biosimilars market, focusing on oncology and immunology biosimilars. - **Pfizer**: A global pharmaceutical company involved in the development and marketing of biosimilars. - **IQVIA Institute**: Provides insights and reports on the biosimilars market, highlighting opportunities and challenges. - **AscellaHealth**: Released a report highlighting the increase in FDA-approved biosimilars and their potential for cost savings in healthcare. - **FDA**: The U.S. regulatory body responsible for approving biosimilars, including recent approvals for denosumab biosimilars. - **CMS**: The Centers for Medicare & Medicaid Services, involved in the reimbursement policies for biosimilars. - **Amgen**: A biotechnology company that develops biosimilars and has a significant presence in the market. - **Teva**: A pharmaceutical company developing biosimilars, including TVB-009P, which has shown promising results in clinical trials. - **Just Evotec Biologics**: A company focused on the rapid development and manufacturing of biosimilars, utilizing advanced technologies. - **Amneal Pharmaceuticals**: A company expanding its pipeline with biosimilars, aiming to provide affordable biologic medicines. - **Celltrion**: A biopharmaceutical company known for developing biosimilars, including recent candidates recommended for approval by the European Medicines Agency. - **Sandoz**: A leader in generic and biosimilar medicines, aiming to lead the US biosimilars market with multiple launches planned. - **Mayo Clinic**: A leading healthcare organization that emphasizes the importance of biosimilars in reducing cancer treatment costs. ### Partnerships and Collaborations - **AscellaHealth**: Released a Specialty & Rare Pipeline Digest detailing new biosimilars and their market impact, emphasizing collaboration in drug commercialization. - **Just Evotec Biologics and Sandoz**: Expanded technology partnership to ensure a long-term commercial supply of biosimilars, focusing on rapid development and manufacturing. - **Bio-Thera Solutions and Intas Pharmaceuticals**: Entered into an exclusive agreement for the commercialization of BAT2506, a golimumab biosimilar. - **Fresenius Kabi and Formycon AG**: Collaborated on the development and marketing of biosimilars for chronic inflammatory diseases. - **Meitheal Pharmaceuticals and King-Friend Industry**: Entered an exclusive licensing agreement to market and distribute new biosimilars in the U.S., expanding their portfolio. - **Fresenius Kabi and Amgen**: A global settlement allowing for the launch of denosumab biosimilars in the U.S. and Europe. - **Evotec and Sandoz**: Expanded partnership to enhance the long-term commercial supply of biosimilars, leveraging advanced manufacturing technologies. - **Blue Shield of California and Fresenius Kabi**: Blue Shield is offering a Humira-referenced biosimilar, Idacio, at a competitive price, bypassing traditional pharmacy benefit managers. - **Organon and Cirqle Biomedical**: Collaboration for research and development of biosimilar candidates, enhancing access to affordable medications. - **Samsung Bioepis and Sandoz**: Commercialization agreement for the biosimilar PYZCHIVA, expanding treatment options for patients. - **Teva and mAbxience**: Signed a worldwide licensing agreement to develop an anti-PD-1 oncology biosimilar, enhancing their partnership for improved healthcare access. - **Accord BioPharma and Bio-Thera Solutions**: Collaboration for the commercialization of BAT2506 in the U.S. market. - **Biocon and Civica**: A strategic collaboration to enhance access to Insulin Aspart in the U.S., addressing insulin affordability issues. - **Celltrion and iQone Healthcare**: Celltrion's acquisition of iQone Healthcare aims to enhance its distribution network and access to biosimilars in Europe. - **Syneos Health and Microsoft**: Partnered to develop a machine learning platform aimed at enhancing the commercial performance of biopharma companies. ### Innovations, Trends, and Initiatives - **Interchangeable Biosimilars**: The increase in interchangeable biosimilars is providing more affordable healthcare options and enhancing patient access. - **Regulatory Advances**: Streamlined approval processes and clearer guidelines are facilitating the development and market acceptance of biosimilars. - **FDA Guidance**: New guidance proposed to ease market entry for biosimilars by allowing applicants to demonstrate interchangeability based on existing data. - **Interchangeability Studies**: Research on the interchangeability of biosimilars is promoting their acceptance among healthcare providers. - **FDA Draft Guidance**: New guidance allows biosimilars seeking interchangeable status to use existing data instead of requiring new clinical studies, streamlining the approval process. - **Biosimilars Training Course**: An online seminar scheduled for October 2024, focusing on global strategies for biotech and biosimilar products. - **Rising Adoption of Biosimilars**: The adalimumab biosimilar market share increased to 22% as of August 2024, driven by private label brands. - **Biosimilars Market Growth**: The global biosimilars market is projected to reach USD 24.2 billion by 2024, driven by the demand for chronic disease management solutions. - **Regulatory Changes**: Recent FDA guidance aims to streamline biosimilar development, reducing costs and timelines. - **Biosimilar Adoption Strategies**: Research and discussions at AMCP Nexus 2024 focused on overcoming barriers to biosimilar adoption, including provider education and reimbursement structures. - **Biosimilar Market Growth**: The biosimilar market is projected to reach a value of $10 billion by 2028, driven by increased approvals and the expiration of biologic patents. - **Regulatory Advancements**: Streamlined approval processes and clearer guidelines are facilitating biosimilar development and market acceptance. - **Patient Affordability Programs**: Programs launched by companies like Boehringer Ingelheim to reduce financial barriers for patients accessing biosimilars. - **Market Growth Projections**: The global biosimilars market is projected to grow to approximately $92 billion by 2031, driven by patent expirations and increased demand for affordable healthcare. - **Growth Projections**: The global biosimilars market is projected to reach USD 24.2 billion by 2024, with a CAGR of 16.5% through 2035. - **FDA Guidance Changes**: Proposed changes to eliminate switching study requirements for biosimilar interchangeability, potentially improving market access. - **Digital Training Tools**: Developed to enhance communication between healthcare providers and patients regarding biosimilar switches, aiming to mitigate the nocebo effect. ### Challenges and Concerns - **Regulatory and Patent Issues**: Biosimilars face significant regulatory challenges, including complex development processes and patent litigation, which hinder market entry. - **Biosimilar Void**: A term describing the uncertainty and challenges in the biosimilars market, affecting competition and patient access. - **Slow Adoption in the U.S.**: Challenges related to reimbursement, provider education, and patient engagement hinder the integration of biosimilars into healthcare. - **Market Acceptance Issues**: Despite the potential for cost savings, healthcare providers remain hesitant to prescribe biosimilars due to concerns about efficacy and safety. - **Regulatory Compliance**: Diverse regulatory environments, particularly in emerging markets, pose challenges for the approval and commercialization of biosimilars. - **Adoption Barriers**: Concerns regarding inconsistent naming standards, regulatory processes, and lack of education about biosimilars hinder their adoption. - **Low Uptake Rates**: Despite potential cost savings, the low uptake of biosimilars raises concerns about their long-term sustainability in the market. - **Immunogenicity Concerns**: Ongoing debates about the potential for adverse immune responses associated with biosimilars. - **Market Access Issues**: High acquisition costs of some biosimilars exceeding reimbursement rates, creating financial challenges for healthcare providers. - **Pricing Strategies**: Brand manufacturers employ tactics that limit biosimilar market entry, impacting their affordability and adoption. - **Patent Litigation Complexity**: The intricate patent landscape delays market entry for biosimilars in the U.S., necessitating reforms for quicker approvals. - **Physician Resistance**: Concerns regarding the safety and efficacy of biosimilars among prescribers may hinder adoption. - **Market Manipulation**: Drug manufacturers and pharmacy benefit managers create confusion that limits the adoption of biosimilars, allowing high-cost brand biologics to dominate. - **Retention Rates**: Some studies indicate lower retention rates for biosimilars following nonmedical switching, raising concerns among healthcare providers. - **Provider and Patient Confidence**: Despite the potential of biosimilars, confidence remains a barrier to acceptance, necessitating education and support. - **Pharmacy Benefit Managers (PBMs)**: Concerns about potential anticompetitive practices as PBMs shift formularies to prefer biosimilars over original biologics. - **High Out-of-Pocket Costs**: Despite savings from biosimilars, patients face high out-of-pocket costs, impacting adoption and use. - **Market Barriers**: Barriers to biosimilar adoption include restrictive payer policies, physician hesitancy, and a lack of patient education, which slow integration into standard medical practice. - **Physician Hesitance**: Lack of education and communication about biosimilars' safety and efficacy contributes to slow adoption.