Biosimilars and generics: Trends in the pharmaceutical industry and the role of primary packaging

What are biosimilars?

Biosimilars are biologically derived medications that are highly similar to biologic drugs that are already approved. While biosimilars are not exact copies of the originals, they show no meaningful clinical difference in terms of quality, safety, and efficacy.

Key characteristics of biosimilars:

• Launched after the original biologic’s patent has expired.
• Provide a cost-effective alternative to original biologics.
• Require careful handling and packaging as their large, complex molecules are sensitive to chemical and physical changes.

What are generics?

Generics are chemically produced copies of original drugs. They contain the same active ingredient, offer the same therapeutic effect, and are administered in the same dosage as the original product.

Key characteristics of generics:

• Significantly reduce drug costs by offering affordable alternatives to branded medications.
• Less complex than biosimilars, they require appropriate packaging to ensure their efficacy and stability.

The role of packaging for biosimilars and generics

Packaging plays a critical role in ensuring the efficacy and success of biosimilars and generics. A poor choice of primary packaging can lead to undesirable chemical reactions, stability issues, or even the need for reformulation.

Specific requirements for biosimilars:

• Ensure stability: Biosimilars are highly sensitive to pH shifts and chemical instability.
• Minimize leachables: Packaging must minimize interaction with the drug.
• Tailored solutions: Since biosimilars are not exact copies, their primary packaging cannot be the same as the original product packaging.

• Cost-efficiency: Packaging must be economical to maintain the cost advantage of generics.
• Reliability: It must ensure the drug's stability and quality, regardless of storage or transport conditions.
• Re-evaluation: Primary packaging needs to be re-evaluated as the original packaging may not meet the latest regulatory and quality standards.

EVERIC® pure: A platform solution for maximum safety and efficiency

EVERIC® pure by SCHOTT Pharma offers unique vial excellence. Made of pure Type I Borosilicate Glass, it is specifically designed to meet the challenges of primary packaging for biosimilars and generics.

Why choose EVERIC® pure?

• Reduced risks: Its design minimizes leachables and delamination risk, ensuring drug stability.
• Flexibility: Pre-tested and standardized solutions provide the ideal foundation for development and production.
• Efficiency: With its chemically stable inner surface, EVERIC® pure efficiently supports both large and small drug batches.

By choosing EVERIC® pure, pharmaceutical companies ensure the stability of their formulations while reducing the risk of delays during development and recalls after launch – a critical advantage in a highly competitive market. EVERIC® pure offers unmatched reliability for your drug products.

Learn more about EVERIC® pure

Conclusion

Biosimilars and generics are indispensable in the modern pharmaceutical landscape. However, their success depends not only on development but also on the right packaging. EVERIC® pure offers an innovative solution to ensure the stability, safety, and efficiency of these medications, helping to accelerate the introduction of new therapies. Since leachable-sensitive biosimilars, generics with high pH formulations, and lyophilized applications may require more complex solutions, SCHOTT Pharma offers the option of inner coatings for vials.