6 Tips For Navigating Emerging Market Biosimilar Regulations

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

In his presentation at the 2016 World Biosimilar Congress USA, Elliot Morales, senior director of regulatory affairs, at Dr. Reddy’s Laboratories, discussed the regulatory landscape for companies planning to introduce biosimilars in emerging markets. A number of these countries, including Russia, Peru, and Colombia, have, on varying levels, established regulatory pathways for biologics and biosimilars. However, these pathways differ from country to country, in turn posing challenges for biosimilar makers when assembling dossiers for market approval. A previous article based on Morales’ presentation highlights the shape of several of these emerging market pathways. However, there were six additional points worth noting from Morales’ presentation which can alter the shape and timeline of a global development program and market approval.

1. Flexibility for nonclinical/clinical studies is key: Manufacturers approaching emerging markets might find their global development programs will need to be flexible to meet a country’s specifications for nonclinical biosimilarity. Countries may differ in what they consider to be relevant species for animal studies. “A company will likely need to extend its global development program in order to satisfy the needs of different jurisdictions,” Morales said. He further specified that a company should present data from its global development program, justifying scientifically the clinical model used or how the animal in nonclinical studies is the most relevant species to be tested. The goal is to justify the study and to come to a mutual understanding. However, at the end of the day, some countries will remain set on having additional or different sets of studies (nonclinical or clinical). For instance, this could be the country’s way of ensuring that local patients are included in trials or that the country is involved in a certain stage of development. In these cases, Morales said a company might find it will need to acquiesce to the country’s request for both the company’s and the country’s mutual benefit.
2. “Go local:” The U.S. and EU have regulatory processes at hand (i.e., the Biosimilar User Fee Act [BsUFA]) for receiving advice over the course of developing a biosimilar. In emerging markets, this is often not the case. In order to answer the questions that may arise, a company must understand the landscape on a local level. Knowing the location well will enable a company to seek out local key opinion leaders, subject matter experts, and other experts who would have a connection to or knowledge of the country’s regulatory body to receive tips on how to best submit a candidate for review.
3. Confidentiality is not guaranteed: Some emerging markets, such as Colombia, have a two-step review process, which begins with a government-hired committee to consider the candidate prior to a formal review. Experts carrying out these reviews tend to be clinicians, academicians, or outside consultants. However, this can raise some issues in terms of confidentiality. As Morales described, when submitting a dossier for approval in the U.S., a company can expect the information contained in the application will remain confidential. In emerging markets, however, companies might find their information becomes available to the competition because of the external contacts used in the review process. 
4. Timelines will vary: Approving a product in an emerging market can take anywhere from one to five years. “It could be a continuous effort to get your product approved,” Morales said. There are several factors that can slow down an approval. For one, a company might have to supplement a dossier with additional information. This data will then need to be revisited. New employees might enter the agency, and the company will need to re-present its case to these new members. Finally, guidelines could change, meaning a company will be held to new standards.
5. Resource shortages impede regulator education: There are training opportunities available through external agencies, such as the WHO. There may also be regional courses held by drug regulatory authorities. However, some emerging markets are faced with a lack of resources and, in turn, are unable to send regulators for training to keep them up to speed. According to Morales, this can lead regulators to “rely on originators or pharma companies to come in and give their view on how things should be done, which is not the case in highly regulated markets.”    
6. Preapproval inspections can be beneficial: As Morales stated, one of the factors that can trigger an approval is a preapproval inspection. While these inspections are carried out in many jurisdictions, a lack of resources can limit certain emerging markets in their auditing abilities. Enter The Pharmaceutical Inspection Co-Operation Scheme (PIC/S). The PIC/S program enables good manufacturing practice (GMP) inspection results to be shared (voluntarily) between PIC/S participating authorities. This program can provide reassurance that a company has been visited and audited by a neighboring or partnering country.