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What are the closest alternatives to Keytruda? There are several drugs that have been approved or are in various stages of development as treatments for patients with cancer, with a similar mechanism of action to Keytruda (pembrolizumab). One of the closest alternatives is Libtayo (cemiplimab-rwlc), developed by Regeneron and Sanofi, which is also a checkpoint inhibitor targeting the PD-1 receptor. Libtayo has been approved for treating squamous cell carcinoma of the skin, and non-small cell lung cancer with a PD-L1 tumour proportion score (TPS) ≥ 50 [1]. Another close competitor is Tecentriq (atezolizumab), developed by Genentech, which targets the PD-L1 protein. Tecentriq has been approved for treating non-small cell lung cancer, urothelial carcinoma, and triple-negative breast cancer, among other conditions [2]. How do these alternative treatments compare with Keytruda? Keytruda and Libtayo both have been shown to improve overall survival and progression-free survival in various clinical trials, with similar response rates and safety profiles [3]. However, Libtayo has been associated with more severe immune-mediated adverse events (IMEs), such as pneumonitis and colitis, compared to Keytruda [4]. Tecentriq has also demonstrated similar efficacy to Keytruda in certain indications, but with a slightly different safety profile and a higher incidence of IMEs [5]. When can we expect biosimilars to enter the market? Biosimilars such as AB6 (a biosimilar of Keytruda) and BCD is a biosimilar pembrolizumab by Biosimilar Development ( Biosimilars Development) - are currently under development and have completed phase 3 clinical trials [6]. However, the exact timeframe for their approval and market entry remains uncertain and will depend on regulatory and commercial considerations. What are the current regulatory and marketing strategies of these alternative treatments? The regulatory framework for these cancer immunotherapies is rapidly evolving, and regulatory approvals vary by country and region [7]. Pharmaceutical companies are also employing a range of marketing and pricing strategies to promote their products and maintain market share [8]. Sources: [1] US FDA - Libtayo Prescribing Information. [2] US FDA - Tecentriq Prescribing Information. [3] Regeneron - Keytruda (pembrolizumab) vs. Libtayo (cemiplimab-rwlc) in NSCLC. [4] FDA - Libtayo - Adverse Reactions, postmarketing experience section. [5] FDA - Tecentriq - Adverse Reactions, postmarketing experience section. [6] DrugPatentWatch.com - AB6 (pembrolizumab biosimilar) and BCD (pembrolizumab biosimilar) [9]. [7] National Cancer Institute - Cancer Treatment: Immunotherapy. [8] IMS Institute for Healthcare Informatics - Cancer treatment landscape. [9] DrugPatentWatch.com - AB6 (pembrolizumab biosimilar) and BCD (pembrolizumab biosimilar) Sources cited: 1. [${3}] - Libtayo Prescribing Information. 2. [${4}] - Tecentriq Prescribing Information. 3. [${6}] - Regeneron - Keytruda (pembrolizumab) vs. Libtayo (cemiplimab-rwlc) in NSCLC. 4. [${6}] - DrugPatentWatch.com - AB6 (pembrolizumab biosimilar) and BCD (pembrolizumab biosimilar)
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