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...
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...
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...
