When it comes to affordable medication options, generics and biosimilars both serve as alternatives to more expensive brand-name drugs, but they are quite different. 🔷 Generics are exact chemical copies of brand-name drugs. Once the original drug's patent expires, other companies can make these copies because they know the exact ingredients and processes used. Generics work just like their brand-name counterparts but are usually much cheaper. 🔷 Biosimilars, however, are a bit more complex. They are based on drugs that come from living organisms, called biologics. Making an exact copy of a biologic is impossible because living organisms vary naturally. Instead, biosimilars are highly similar to the original but not identical. This means they require extensive expertise to ensure they are just as safe and effective as the originals. At Niromed, we leverage our deep industry knowledge and regulatory experience to navigate these complexities. Our team ensures that each biosimilar meets all safety and efficacy standards, providing reliable and cost-effective treatment options. #Niromed #Biosimilars #Generics #PharmaceuticalExpertise #HealthcareEducation
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Comprehensive Comparison: ANDA (Generics) vs. Biosimilars 🔍 Composition - Generics: Chemically synthesized, identical to brand-name drugs (e.g., ibuprofen). - Biosimilars: Derived from living organisms, similar but not identical to originals (e.g., adalimumab). 🛤️ Approval Process - Generics: Approved via bioequivalence studies, easily interchangeable. - Biosimilars: Require rigorous testing, not automatically interchangeable. 🏭 Manufacturing - Generics: Simple chemical synthesis, consistent across batches. - Biosimilars: Complex biotechnological processes, potential batch variability. 📜Regulation - Generics: Ensured bioequivalence by FDA and other bodies. - Biosimilars: Extensive testing to prove similarity. 📈 Market Impact - Generics: Enter market post-patent, significantly reduce costs. - Biosimilars: More affordable than biologics but costlier to produce than generics. For a detailed comparison, check out the full PDF. If you find any discrepancies or have feedback, please let us know and repost this message. #PharmaInsights #GenericsVsBiosimilars #HealthcareInnovation #PharmaceuticalIndustry #Biosimilars #Generics #DrugDevelopment #FDAApproval #Biotech #fda #pharma #regulatoryaffairs #regulatoryintellingence #kaust #gcc #middleeast #knowledgsharing
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Unlocking the potential of bioburden testing! 🧫 Dive into the market drivers and opportunities shaping this vital industry. From strict regulations to emerging market expansions, discover the key factors fueling growth. Explore more: https://lnkd.in/dhWZHfcK #coherentmarketinsights #bioburden #testing #medicaldevices #sterilization #validation #bioburden #regulations #biotechnology #marketgrowth #marketresearch #pharmaceutical #medical
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Docteur en Génie des Procédés et Biotechnologie ❚ Consultant Senior Commissioning, Qualification et Validation (Équipements, HVAC, Procédés et utilités) ❚ Chercheur Scientifique, Formateur et Conférencier
Would you like to learn about how to perform a shipping validation study? This side deck was presented at the IPQC in 2015. It consists of 2 case studies (case study 1: Shipping medicinal product from Canada to Europe and case study 2: shipping medicinal product from Canada to India) which take you through the key considerations for validating your shipping packaging. If you would like to learn more on this or any other Good Distribution Practice related topics, please like share and follow me on LinkedIn. #shipping #packaging #validation #gdp #pharmaceutical #biotechnology
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Thoughts on this? >> Drug Channels News Roundup, June 2024: Cordavis Humira Update, OptumRx’s New Biosim Biz, Generic Drugs' Wild Ride, IRA Predictions, and Dr. G on Med School >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #healthcare #productmarketing
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PHARMA-TECH: As per a report released by Bessemer Venture Partners, the $50 billion Indian pharmaceutical market is expected to grow at ~8% CAGR for the next 5 years and is poised for transformation. Click to read: https://lnkd.in/de6a4Rr2 #BioVoiceNews #medtech #biotech #pharmatech #pharma #sales #marketing #biovoicenews
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Around 60% of all drugs are synthetic compounds, while 40% of new drugs approved between 1981 and 2019 are derived from natural sources. Both natural products and synthetic compounds play a crucial role in pharmaceutical development. The best approach often involves a combination of both strategies. Natural products offer a rich source of novel drug leads, while synthetic chemistry allows for optimization and large-scale production. Ultimately, the choice between a natural or synthetic compound depends on the specific needs of the drug being developed. Share your thoughts below. #Pharma #Trillioni #TrillioniPharma #TrillioniPlatform #TrillioniPharmaPlatform #PharmaceuticalManufacturing #Manufacturing #PharmaceuticalProducts #Medicine #Health #HealthCare #Natural #Products #NaturalProducts #SyntheticCompounds
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The top Biotech & Pharma stories in one daily email - TLDR Biotech 🧬💊 | Founder, Head Editor | Sales Strategy and Consulting 🤝📈
The FDA approved 21 "novel" drugs in the first half of 2024. By "Novel" drugs, the FDA means "new drugs never before approved or marketed in the U.S." The infographic below covers them all - including a truncated indication and drug modality. Unsurprisingly for drug modality, pure-play small molecules led the pack with just over half (12 in total) of the approvals. Want the higher resolution version (or better yet, spot any mistakes 😬)? Drop a comment below. —————————— Comprehensive, daily coverage of the biotech and pharma industry, straight to your inbox (and all in one email) - that's TLDR Biotech. 🧬🔔 #biotech #pharma #pharmanews #biotechnews #tldrbiotech
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Release testing is a critical aspect of drug development, ensuring the safety, identity, quality, purity, strength, and potency of raw materials, drug substances, and drug products. With evolving drug modalities, manufacturing and testing processes become more complex. Swipe left to explore some of the factors contributing to this complexity. Solvias takes great pride in being chosen to perform release testing on the world's first CRISPR-based gene-editing therapy, CASGEVY™, developed by @Vertex Pharmaceuticals, as outlined in our recent press release. 🔗 Press release: https://lnkd.in/eqWFpz3a Contact us at info@solvias.com to discover how Solvias can assist you in navigating the logistical, regulatory, and technical requirements to bring your innovation to its destination. #genetherapy #CRISPRtherapeutics #releasetesting #casgevy
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Release testing is a critical aspect of drug development, ensuring the safety, identity, quality, purity, strength, and potency of raw materials, drug substances, and drug products. With evolving drug modalities, manufacturing and testing processes become more complex. Swipe left to explore some of the factors contributing to this complexity. Solvias takes great pride in being chosen to perform release testing on the world's first CRISPR-based gene-editing therapy, CASGEVY™, developed by @Vertex Pharmaceuticals, as outlined in our recent press release. 🔗 Press release: https://lnkd.in/eqWFpz3a Contact us at info@solvias.com to discover how Solvias can assist you in navigating the logistical, regulatory, and technical requirements to bring your innovation to its destination. #genetherapy #CRISPRtherapeutics #releasetesting #casgevy
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The use of LAL (limulus amebocyte lysate) testing is considered the norm in the pharmaceutical production industry. It is crucial to maintain a high level of cleanliness in the factories that produce medications. However, the use of these tests can be expensive and difficult due to their dependence on horseshoe crab blood for production. Fortunately, our recombinantly generated rLAL testing provides a solution to these challenges. It will eliminate these barriers of cost and scarcity, as we will be able to produce these tests affordably, abundantly, and in a readily available manner. This advancement will not only benefit the pharmaceutical industry but also any industry where sterility is needed! #biotechnology #lifescience #lifesciences #biomedicalscience #technology #technews #newtech #latesttech #latesttechnews #futuretech #innovation #techindustry #tech #biotech #savethecrabs
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