Biosimilars: Regulatory Trends And Manufacturing Considerations

August 28, 2018

Unlike well-defined chemical medicinal products and their generic counterparts, biologics and their biosimilar counterparts employ sophisticated bioprocessing technologies that utilize living systems for their manufacture. Because these complex heterogeneous protein molecules are produced in living systems, their exact characteristics are subject to inherent batch-to-batch variability. Given the variability of biologics characteristics including its manufacturing complexity, biosimilars must undergo a much more rigorous regulatory pathway for approval compared to generic drugs.

Spotlight

Zynerba Pharmaceuticals

Zynerba (NASDAQ: ZYNE) is dedicated to improving the lives of people with rare and near rare neuropsychiatric disorders where there is a high unmet medical need by pioneering the development and commercialization of next-generation pharmaceutically-produced cannabinoid therapeutics formulated for transdermal delivery. Cannabinoids interact with specific receptors throughout the body to produce pharmacologic effects, primarily in the CNS and immune systems. Transdermal delivery has the potential to reduce adverse effects associated with oral dosing because it allows the drug to be absorbed through the skin directly into the bloodstream, avoiding the gastrointestinal tract and lessening the opportunity for GI-related adverse events. It also avoids first-pass liver metabolism, potentially enabling lower dosage levels of active pharmaceutical ingredients with a higher bioavailability and an improved safety profile. Zynerba’s lead patent-protected product candidate in clinical development i

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