Delving deeper into the promising landscape shaped by Ontario’s innovative biosimilar regulations. Discover how these policies are fostering enhanced accessibility for patients and driving positive transformations in the pharmaceutical industry.
There are a few similarities and a few differences between biosimilars and generic drugs. A generic drug is an exact copy of its reference biological and has the same chemical composition. Whereas, a biosimilar is very similar to the reference drug but not an exact copy.
Biosimilar drugs are completely safe as they require clinical trials and FDA approvals before they are permitted to be used on patients. While generic drugs can be used interchangeably with biologics after getting their FDA approval, this is not the case with biosimilars which require an additional FDA approval step to be used interchangeably.
One of the most significant benefits of biosimilars is that they increase patient access to life-saving medications. Biosimilars are often used to treat chronic diseases that require long-term treatment, which can be prohibitively expensive for some patients. Biosimilars provide a cost-effective alternative that allows more patients to access the medications they need.
A new policy was passed in December 2022, by Ontario to join the other provinces in expanding the use of biosimilars in the public health system, which is a significant development in the Canadian biologics industry. From March 31, 2023, beneficiaries of the Ontario Drug Benefit (ODB) program, who are currently receiving an originator biologic drug, will transition to a biosimilar version that has been approved by Health Canada. To enable a smooth transition, a grace period has been allotted between March 31, 2023, and December 29, 2023, during which ODB program recipients can switch from an originator biologic to a biosimilar version while maintaining ODB program coverage for their biologic drug. ODB program recipients will need to switch to the biosimilar version before December 29, 2023, to keep receiving ODB program coverage for their biologic drug, unless certain exceptional circumstances apply.
If a patient is taking Copaxone®1, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, or Rituxan®, they may need to switch to the biosimilar drug to get coverage through the ODB program. For a complete list, and details including exemptions, visit the Ministry of Health site.
Biosimilar regulations in Ontario have a significant impact on patients. The use of biosimilars can help reduce the overall cost of healthcare, which can make medications more accessible to patients who may not have been able to afford them previously. Biosimilars also provide a cost-effective alternative to expensive reference products, which can help improve patient outcomes. Patients who have access to effective medications are more likely to experience positive health outcomes and have a higher quality of life.
Patients who switch from a reference product to a biosimilar may experience different side effects or efficacy outcomes. Therefore, it is essential that patients are closely monitored when switching from a reference product to a biosimilar to ensure that the switch is safe and effective.
By promoting the development and production of biosimilars, the government is promoting innovation and competition in the pharmaceutical industry. Increased competition can lead to lower costs and more innovation, which can benefit patients by providing them with access to a wider range of safe, affordable, and effective medications.
However, biosimilar regulations also present challenges for the pharmaceutical industry. Biosimilars are more complex and difficult to produce than traditional small-molecule drugs, which means that the production process is more expensive. In addition, biosimilar regulations require significant testing and clinical trials, which can increase the cost of development.
Despite these challenges, many pharmaceutical companies are investing in the development and production of biosimilars. The biosimilar market is expected to continue to grow in the coming years, which presents significant opportunities for companies that invest in this area. With the rising inflation increased shortages in the Healthcare staff and long waiting times, this is a ray of hope in terms of getting affordable treatment for critical diseases. With the expansion of Ontario’s biosimilar policy, we are headed toward a positive change with accessible medications to low-middle-income families in Ontario.