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Pharmaceutical Regulatory Affairs: Open Access

Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access
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Biosimilars High Impact Factor Journals

The biosimilar is biologic medical product , also known as biologic, which is highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of the pharmaceutical quality, safety and efficacy that apply to all biological medicines.The Biosimilars are officially approved versions of original "innovator" products and can be manufactured when original product's patent expires. Reference to the innovator product is an integral component of the approval.While with generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle. The biosimilar is not regarded as a generic of a biological medicine.

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Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

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