Biosimilars
Pkinetix biosimilars experts are some of the best in Latin America and possess a deep and nuanced understanding of every aspect of the biosimilars business.
Our Latin American biosimilars services include:
- Manufacturing and tech-transfer support.
- PPP Negotiation in Brazil.
- Commercialization support across Latin America.
- Expert dossier assembly and submission from Mexico to Argentina.
- Dossier defense (“cortes de plazo”).
- Meetings with regulatory authorities at ANVISA, INVIMA, COFEPRIS, ANMAT etc.
- Phase I-III clinical trials services as well as PK studies for biosimilars.
Latin America has become an ideal region for the development and marketing of biosimilars. The region’s burgeoning middle classes, growing healthcare budgets, generics driven pharmaceutical markets and large and easily accessible treatment naive patient populations make it a necessary part of any intelligent global biosimilars development strategy.
As regulatory authorities from Mexico to Argentina follow the FDA’s and EMA’s lead in establishing regulatory pathways for biosimilars, opportunities exist in the region for savvy generics companies to design regulatory strategies to achieve timely registrations which can be used to market their products in those countries as well as later introduce them into other global markets.
What reference product will you be required to use in Mexico? Will you need to conduct local PK/PD, preclinical or clinical studies in Chile? If so, where and how will these be carried out? What will you need to demonstrate in terms of safety, efficacy and quality in Brazil? Will you need a risk management plan in Colombia? If so, what should it look like? Will you be required to include Peru in your global development plan? How does the process at Uruguay’s ministry of health or Chile’s ISP vary from that of Mexico’s COFEPRIS? How long does ethics committee approval take in Costa Rica? What are the costs involved in each place? What can go wrong? Pkinetix will help you answer these and all other questions that appear along the path to successful registration of your biosimilar. We talk on your behalf to regulators in each country from very early on in the process to avoid costly surprises.
Pkinetix has both the big picture view of Latin America and the local in-country expertise as well as the scientific, technical and regulatory know-how needed to design and implement a successful biosimilar development and registration strategy across the region. Our firm understands like few others the region’s uneven patchwork of regulatory frameworks, the complexities of each local market and the functioning of each individual notified body and puts this knowledge to work for you.