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Learning curves in the current clinical biosimilar development

May 20, 2020 | Registration Process

Many biosimilar developers need to think outside the box when structuring their clinical trials. As an example, one could discuss with a supervisor whether it is insufficient to investigate only one indication in the comparative efficacy study and rely on...

Clinical tests of biosimilars in comparison to biopharmaceuticals

May 6, 2020 | Registration Process

Phase 3 clinical trials of biosimilars are beneficial for patients because they do not have to be afraid of receiving a placebo. They receive either the reference product or the biosimilar, so that they receive treatment in any case. In addition, it may be interesting...

Is your internal strategy prepared for uncertainties in the development of biological drugs?

Mar 19, 2020 | Registration Process

The pharmaceutical industry’s former dependence on blockbuster drugs has evolved to focus on developing drugs that address the unmet needs of smaller patient populations. These niche drugs are most commonly found in the form of biopharmaceuticals, which have...

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