Biotherapeutics play an important role in modern medicine and have a profound impact on patients with serious diseases. A biotherapeutic is a medical product manufactured or extracted from biological sources. Composed of larger and more complex molecules than chemically-synthesized medicines, biotherapeutic medicines require sophisticated production and control processes in order to maintain their safety and efficacy over time.

In recent years, the expiration of patents for many original biotherapeutic medicines has created new opportunities in the market for biologics. These products, referred to as similar biotherapeutic products or biosimilars, are similar to original biotherapeutic medicines in terms of quality, safety, and efficacy.

While biotherapeutic and biosimilar medicines have opened up new avenues for delivering innovative treatments for diseases to patient populations around the world, some regulatory issues still need to be addressed.  These concerns relate to accelerating access to new medicines, as well as improving regulatory oversight, in order to provide patients with the best treatment possible.

Technological advancements in the field of biotherapeutics continue to provide opportunities to treat an increasing number of diseases. However, specific regulatory and evaluation methods necessary to ensure the safety of biotherapeutic products often prevent the timely approval of new medicines.

Regulatory review processes for biosimilars can also be challenging.  An extensive development program, including head-to-head analytical and clinical studies, is necessary to confirm that a biosimilar has similar quality, safety, and efficacy to the originator product.  Regulatory agencies therefore require the resources and time to review the resulting comprehensive dossiers.  In some countries, the regulatory agencies can only start their reviews once a reference country has issued a license, potentially causing further delays to the approval of a biosimilar.

After a regulatory approval, biotherapeutics and biosimilars face ongoing challenges in managing manufacturing and supply networks.  Biotherapeutics are sensitive to manufacturing conditions and regulators will therefore review a manufacturer’s data prior to approving certain changes.  In some countries the procedures for reviewing such changes can delay implementation of important manufacturing and product improvements by years.

To ensure that manufacturers can more efficiently develop and deliver quality, safe, and effective biotherapeutics and biosimilars, regulatory agencies must develop faster regulatory systems.  These reforms, along with more efficient access and reimbursement procedures, will promote the development of new therapies and increase competition for existing biotherapeutics, and enable access to patients who need them.

As more biologic and biosimilar products enter the market, national regulations will need to cover multiple sectors, moving beyond regulatory approval. Due to the structural complexity and sensitivity of biotherapeutics and their ability to elicit immune responses in patients, sound regulatory standards, as well as strong post-market safety surveillance systems, are necessary in order to ensure the safety of patients around the world. Effective oversight in these areas will help improve physician expertise and patient involvement, manage risk, and maximize benefits for healthcare systems.

As a chemical engineer by background, I have worked extensively to address the development, manufacturing, and quality oversight of biotherapeutics.  Biotherapeutic medicines have significantly impacted our ability to treat conditions and save patient lives. As patients ourselves, it is therefore crucial that we address the issues surrounding biotherapeutics in a way that will best benefit patients. Thus, it is vital that regulators, manufacturers, and health systems start collaborating in order to encourage the development of new biotherapeutics and high quality biosimilars thereby increasing access to patients.

Author

• Gino Gramp