Midas Pharma is the Marketing Authorisation Holder (MAH) of a biosimilar
With the launch of the first biosimilar in UK and EU, Midas Pharma has taken over the MAH role of a marketed product for the first time in its history, showing robust pharmacovigilance and quality systems are in place. The ophthalmic drug is on the market in the UK since July 2022, followed by the launch in Germany in November 2022 and further launches in Europe in 2023.
As required when taking over such pharmaceutical responsibility, Midas Pharma has nominated a qualified person responsible for pharmacovigilance (QPPV) and has established a pharmacovigilance (PV) system according to the applicable legal frameworks. A robust PV system is an essential component for ensuring patients’ safety and related operative activities: Midas Pharma is able to detect, assess and report the adverse events related to its medicinal products and offers the entire ICSR management, data collection, triage, 4-eyes review, medical assessment and submission to authorities, including reconciliation services for our business partners.
The QPPV of Midas Pharma is responsible for the pharmacovigilance system maintenance and is the single contact point for Health Authorities on a 24-hours basis. Having an QPPV who demonstrates expertise, knowledge, leadership, and responsibility for the PV system allows Midas Pharma to offer corresponding services, also as a backup for other pharmaceutical companies.
Scalable PV solutions according to specific needs and regulatory requirements
The whole pharmacovigilance system under responsibility of Midas Pharma is described in detail in the pharmacovigilance system master file (PSMF), which has been registered in the EU and which is regularly reviewed and updated. The management of the PSMF is in line with the continuously changing regulatory landscape and can be offered by Midas Pharma for third parties as well.
Moreover, Midas Pharma implemented further legally required pharmacovigilance activities for its product such as e.g., signal management, screening of scientific literature, setting up of agreements with partners, creation of periodic safety reports and risk management plans. Our experienced and motivated team, consisting of pharmacists and a biologist, can expand those PV solutions to other products according to the specific needs of each partner.
Sometimes, the complexity of safety obligations requires implementation of additional risk minimization measures in form of educational materials for certain products. Educational materials are important and specific tools, which should be created by the company and approved by national authorities based on different local requirements before the first commercialization of the product. This process includes the alignment with each authority, preparation of booklets, dissimilation to the targeted groups, creation of audio contents and specific web page for patients with QR codes access. Only in the last year, Midas Pharma developed, finalized and distributed educational materials in approximately 15 countries. This important experience can be useful in the future for meeting the very different expectations of the competent authorities, but also for other medicinal products in a smooth workflow.
"The successful launch of the ophthalmic product in a large number of countries shows that Midas Pharma is well prepared for the role as MAH.
Years of preparation and experience, well-established interdisciplinary cooperation of the Midas Pharma’s knowledgeable in-house experts are a solid base for further projects.”
Director Pharmacovigilance | EU-QPPV, Stufenplanbeauftragte
Nowadays, Midas Pharma can offer its expertise in a prompt and qualified manner in the following pharmacovigilance fields:
- ICSR Management
- EU QPPV and back-up
- Literature screening
- Benefit-Risk Evaluation
- Signal management
- Safety writing
- Local PV services
- Risk minimization measures