{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:54:52Z","timestamp":1787964892252,"version":"build-2784847793"},"reference-count":172,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2022,12,5]],"date-time":"2022-12-05T00:00:00Z","timestamp":1670198400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Biologic-based medicines are used to treat a variety of diseases and account for around one-quarter of the worldwide pharmaceutical market. The use of biologic medications among cancer patients has resulted in substantial advancements in cancer treatment and supportive care. Biosimilar medications (or biosimilars) are very similar to the reference biologic drugs, although they are not identical. As patent protection for some of the most extensively used biologics begins to expire, biosimilars have the potential to enhance access and provide lower-cost options for cancer treatment. Initially, regulatory guidelines were set up in Europe in 2003, and the first biosimilar was approved in 2006 in Europe. Many countries, including the United States of America (USA), Canada, and Japan, have adopted Europe\u2019s worldwide regulatory framework. The use of numerous biosimilars in the treatment and supportive care of cancer has been approved and, indeed, the count is set to climb in the future around the world. However, there are many challenges associated with biosimilars, such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability. The purpose of this review is to provide an insight into biosimilars, which include various options available for oncology, and the associated adverse events. We compare the regulatory guidelines for biosimilars across the world, and also present the latest trends and challenges in medical oncology both now and in the future, which will assist healthcare professionals, payers, and patients in making informed decisions, increasing the acceptance of biosimilars in clinical practice, increasing accessibility, and speeding up the health and economic benefits associated with biosimilars.<\/jats:p>","DOI":"10.3390\/pharmaceutics14122721","type":"journal-article","created":{"date-parts":[[2022,12,5]],"date-time":"2022-12-05T08:10:57Z","timestamp":1670227857000},"page":"2721","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Biosimilars in Oncology: Latest Trends and Regulatory Status"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9729-5447","authenticated-orcid":false,"given":"Deeksha","family":"Joshi","sequence":"first","affiliation":[{"name":"Chitkara College of Pharmacy, Chitkara University, Rajpura 140401, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rubiya","family":"Khursheed","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, Lovely Professional University, Phagwara 144411, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4783-0293","authenticated-orcid":false,"given":"Saurabh","family":"Gupta","sequence":"additional","affiliation":[{"name":"Chitkara College of Pharmacy, Chitkara University, Rajpura 140401, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diksha","family":"Wadhwa","sequence":"additional","affiliation":[{"name":"Chitkara College of Pharmacy, Chitkara University, Rajpura 140401, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2979-1590","authenticated-orcid":false,"given":"Thakur Gurjeet","family":"Singh","sequence":"additional","affiliation":[{"name":"Chitkara College of Pharmacy, Chitkara University, Rajpura 140401, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumit","family":"Sharma","sequence":"additional","affiliation":[{"name":"Delhi Pharmaceutical Sciences and Research University, New Delhi 110017, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sejal","family":"Porwal","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Amity University Lucknow, Lucknow 226028, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swati","family":"Gauniyal","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, KLE College of Pharmacy, Hubballi 580031, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sukriti","family":"Vishwas","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, Lovely Professional University, Phagwara 144411, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay","family":"Goyal","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Government Medical College, Patiala 147001, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaurav","family":"Gupta","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Suresh Gyan Vihar University, Mahal Road, Jagatpura 333031, India"},{"name":"Department of Pharmacology, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai 602117, India"},{"name":"Uttaranchal Institute of Pharmaceutical Sciences, Uttaranchal University, Dehradun 248007, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1688-8043","authenticated-orcid":false,"given":"Rajaraman D.","family":"Eri","sequence":"additional","affiliation":[{"name":"School of Science, STEM College, RMIT University, Melbourne, VIC 3001, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kylie A.","family":"Williams","sequence":"additional","affiliation":[{"name":"Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, NSW 2007, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7507-1159","authenticated-orcid":false,"given":"Kamal","family":"Dua","sequence":"additional","affiliation":[{"name":"Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, NSW 2007, Australia"},{"name":"Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, NSW 2007, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3823-6572","authenticated-orcid":false,"given":"Sachin Kumar","family":"Singh","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, Lovely Professional University, Phagwara 144411, India"},{"name":"Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, NSW 2007, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,12,5]]},"reference":[{"key":"ref_1","first-page":"10","article-title":"Equivalent Recombinant Human Insulin Preparations and their Place in Therapy","volume":"11","author":"Sandow","year":"2015","journal-title":"Eur. 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