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The rise of complex OSD generics: Understanding development challenges

October 24, 2024

The oral solid dose (OSD) contract manufacturing market is experiencing high growth levels and is expected to rise in value from $37.82 billion in 2024 to $57.02 billion in 2032.

While traditional OSD generics remain essential, the pipeline is shifting toward complex generic OSDs — difficult-to-manufacture formulations that often require extended-release or modified-release profiles.

From the need for advanced techniques, expertise and capabilities to navigating uncharted regulatory pathways, pharmaceutical companies are increasingly reaching out to outsourcing development and manufacturing partners to streamline their journey to market.

But what are the challenges, and how can the right partner help you overcome them with confidence?

What’s leading the trend toward complex generics?

Several factors contribute to the rise in demand for complex generics, including:

  • Patent expirations

The patents for many blockbuster drug products are expiring, opening the door to pharma companies looking to capitalize on the market opportunity by developing their generic versions.

  • Therapeutic advantages

Many complex generics can offer better therapeutic benefits over traditional generics, making them a more attractive option for both patients and healthcare providers.

  • Market differentiation

Companies that develop their own complex generics may be better able to differentiate themselves within a saturated market and can command more competitive pricing.

What are the development challenges?

Complex generic formulations often require extended-release or modified-release profiles that are designed to control the rate at which the active pharmaceutical ingredient (API) is released. They offer significant advantages, including improved efficacy, reduced side effects and enhanced patient compliance.

However, they can also present significant development challenges. If left unaddressed, these can lead to costly delays or project failure. These challenges include:

  • Advanced manufacturing techniques and stringent quality controls

Sophisticated manufacturing processes and rigorous quality control measures are required for pharma companies looking to replicate the complex release mechanisms of brand-name generics. This necessitates specialized equipment, expertise in formulation, material science, process engineering and strict adherence to regulatory requirements.

  • Ensuring bioequivalence

Making sure that their drug product performs in the same way as the brand drug is a key regulatory requirement for pharma companies developing complex generics. Achieving this bioequivalence can be a challenging task due to the intricate nature of these formulations.

  • Navigating regulatory pathways

The road to securing regulatory approval for complex generics is not a straightforward one, often being less defined than that for traditional generics. To avoid uncertainty and reduce the risk of delays, companies must carefully plan and collaborate with regulatory agencies at every key stage.

  • Circumventing Intellectual Property

The brand formulation and manufacturing process could be under patent protections which can severely impede generic developers from replicating and achieving Q1/Q2 formulations for complex OSDs. In addition, there is a possibility that multiple patents are files not just covering the active ingredient but also the formulation and release mechanisms.

  • Stability and Shelf-life

Ensuring the stability of complex OSDs over their shelf life is often difficult, especially for drugs with modified-release properties or sensitive APIs. Exposure to moisture, heat, or light can affect the drug’s stability and performance.

  • Batch to Batch Reproducibility

Maintaining consistent quality and performance across batches can be difficult in complex OSDs, particularly for those with sophisticated drug-release mechanisms.

Each of these factors contributes to longer development timelines and higher costs, making the pursuit of complex generics a high-risk, high-reward endeavor for pharmaceutical companies. Nevertheless, by working with the right specialist partners, they can streamline their journey to market.

How can product sponsors maximize their chances of success?

CDMOs are a critical element in successfully bringing complex drug products to market and can prove instrumental in navigating the challenges presented by complex generics. The right CDMO partner should be able to provide:

  • Specialist expertise

A partner with a proven track record in complex generics will have the knowledge and skills needed to navigate the intricacies of formulation development, Quality by Design (QbD) approach to drug product manufacturing and securing regulatory compliance.

  • Advanced manufacturing technologies

Partners with access to state-of-the-art manufacturing technologies and specialist analytical capabilities necessary for producing high-quality complex generics will be better placed to streamline the journey to market.

  • Regulatory guidance

The regulatory landscape can be a challenging one to navigate, but the right CDMO partner will be able to provide valuable regulatory support to help secure compliance with relevant guidelines.

Working with the right CDMO partner could mean the difference between a smooth journey to market for your complex generic drug project or one laden with challenges and delays. But how can you be sure you’ve found the right partnership for your project?

To find out more about the key questions you must ask potential partners before selecting the right CDMO for your drug project, download our recent eBook, Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development.