The pharmaceutical industry revolves around research and development, with drug flow safeguarded by patents to ensure returns on investment. After patent expiry, price competition emerges, as manufacturers can replicate the original product. Generic versions of branded drugs, like those that appeared when Bayer's patent of aspirin expired in 1917, play a crucial role, allowing off-patent medicines to be sold at lower prices than their originals. While generics are well-established, newer biosimilars remain less prevalent.
Biosimilars, defined by the International Alliance of Patients’ Organizations (IAPO), closely resemble approved biological medicines. Production of biosimilars, using the same active ingredient as the original once its patent has lapsed, results in a highly similar but not identical version. Any differences must not affect quality, safety, or efficacy. Unlike traditional drugs, biologics come from living cell cultures, making manufacturing intricate. They consist of multiple proteins and molecules, making them larger than conventional drugs. Despite their complexity and sensitivity to storage conditions, biosimilars have become highly popular and effective in treating many diseases.
Comparing biosimilars to innovator products is more intricate than assessing generic equivalents of conventional drugs. Biological drug performance hinges on production and purification methods, with different formulations altering immunogenicity. Unlike conventional generics, demonstrating bioequivalence isn't sufficient.
Generics have made medicines more affordable and accessible, constituting over half of global pharmaceutical use by volume but only 18% by value. They're a widely adopted healthcare technology, resembling the reference drug in bioequivalence to achieve the same therapeutic effect.
A generic drug, available after the patent protecting the brand expires, mirrors the reference drug's bioequivalence for the same therapeutic effect. These medicines undergo the same stringent controls as originator products and are often made by the same company. They share the original's active ingredients, dosage form, strength, and benefits, working identically in the body.
Patents drive the pharmaceutical industry, but after expiry, generics and biosimilars step in, offering cost-effective alternatives. Biosimilars mimic approved biological medicines and require thorough comparison with reference products. Generics, widely adopted globally, provide equivalent therapeutic effects at lower costs. Both generics and biosimilars play critical roles in expanding access to essential medicines.
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