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Navigating the Challenges of Biopharma Product Launches: A Blueprint for Success

PM360

The landscape is highly competitive with new prescription medications launching worldwide each year. Early shaping of the label during clinical trial design, risk mitigation, and avoiding approval delays are crucial for seizing a competitive advantage.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

Others are made by big pharma giants like Boehringer Ingelheim , Novartis , or Pfizer , which has raised the expectations for a competitive market. . Although AbbVie will now face competition from these products, it has built a strong market for Humira, says Hlávka, adding that it will likely continue reporting significant revenues.

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