"There is a huge opportunity for biosimilar manufacturers to capitalize on market opportunities and bring more affordable medicines to the market."

Graham Reynolds,
Vice President and General Manager - Global Biologics, West Pharmaceutical Services, Inc,
Graham Reynolds, Vice President and General Manager - Global Biologics, West Pharmaceutical Services, Inc, in an email interaction with Mahesh Kallayil, shares insights on trends in the biosimilar market and improving patient experiences through optimized biologic drug delivery systems

Could you please tell us about West's journey so far? What are the key thrust areas for West?

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Founded in 1923, we have a long history of working side-by-side with the top pharmaceutical and biotechnology companies around the globe to meet th with more than 50 locations around the world, including a manufacturing facility in India's Sri City Special Economic Zone.

West offers proprietary packaging, containment and drug delivery products, including:
  • Stoppers and seals for injectable packaging systems
  • Syringe and cartridge components
  • Self-injection systems
  • Containment and delivery systems
Additionally, we provide contract manufacturing services, harnessing a powerful combination of innovation, technology infrastructure and expertise to serve customers in the pharmaceutical, medical and consumer industries. We offer quality, safety and reliability in injection molding, contract assembly and finished packaging.

Our top priority is delivering quality products that meet the exact specifications and quality standards our customers require and expect. This focus includes excellence in manufacturing, scientific and technical expertise as well as management.

Please elucidate over the key difference between biosimilars and bio betters?

Biosimilars are a type of biological product that are licensed (approved) by regulatory agencies because they are highly similar to an already approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product."Bio-Betters"differ from biosimilars in that they are not identical to the original product and have been designed to have some clinical advantage. This term may not have an official designation, but is commonly used for those biosimilars that demonstrate benefits over and above those of the innovator and can, therefore, not be classed as biosimilars.

What are latest global trends in biosimilar drug delivery?

It's important to first talk about an overarching trend in the biopharmaceutical industry: a shift toward specialty care and patient-centric, precision-based medicine. With this as a driver, increased competition and the healthcare industry's focus on costs and qualitybased metrics are spurring drug companies to engineer better patient experiences into their treatments. This has particular implications for drug delivery for biosimilars and other biologics: biopharmaceutical manufacturers are focusing on the drug's delivery system earlier in the drug development process and working with delivery system manufacturers to create administration systems that are easy and convenient for patients to use, and can help differentiate drug products from other competitors.

Other notable trends include:
  • A rise in the patient as the decision maker, rather than the provider, driven by better access to information, payer formulary, copay and benefit tiers
  • Increasing access to continuous and integrated medical/patient data, driven by payers, physicians, hospitals and regulatory agencies
  • Increased patient access in developing nations, driven by lower-cost medicines and biosimilars
Specifically, for biosimilars, drug makers will often aim to provide a delivery system that offers the same general mode of action, but they may have options to offer improved systems. As an example, if the innovator's product is delivered by subcutaneous injection by an autoinjector or other device, a biosimilar should use the same basic route of administration (subcutaneous injection), but the injection system for the biosimilar could be different from the innovator's injection system. A prospective biosimilar applicant will not be able to obtain licensure under section 351(k) for its product when a design difference in the delivery device or container closure system results in any of the following:
  • A clinically meaningful difference between the proposed product and the reference product in terms of safety, purity, and potency;
  • A different route of administration or dosage form; or
  • A condition of use (e.g., indication, dosing regimen) for which the reference product has not been previously approved; or otherwise does not meet the standard for biosimilarity.
What is the current status and future growth of biosimilar drug delivery in India?

The market for biologics is continuing to grow in India and around the world. As patents expire on marketed biologics, there is a huge opportunity for biosimilar manufacturers to capitalize on market opportunities and bring more affordable medicines to the market. This means being ready to file first, and that requires having a plan to bring the biosimilar to the market, and to the patient, quickly and efficiently with innovative drug delivery systems that can help their products stand out.

Today and into the future, it is important for biosimilar manufacturers to pair their injectable drugs with delivery systems that patients want to use. This means incorporating design features that provide ease of use, versatility and adaptability to address emerging challenges in administration. This presents significant opportunity for packaging and delivery system manufacturers to design innovative, integrated delivery systems that not only function effectively, but are also designed to be easy and intuitive for patients to use.

In your opinion, which are the key processes that need to be in place for India to be globally competent in this space?

Biosimilars, as the name suggests, are not exact copies of the drug itself, and must be proven to be as safe and effective as the innovator's product. This also means that manufacturing facilities and regulatory filings need to meet the requirements of the market that is being served. Many biologic drugs use delivery systems such as autoinjectors for self-injection, needle safety systems or reconstitution devices, and these systems, as well as the drug itself, also need to be recreated to ensure equivalency to the innovator. Selecting the appropriate container and delivery system can often be as important as the drug molecule in ensuring success.

Biosimilar manufacturers often lack the budget to create a custom-made delivery system for their drug, so their product must be delivered in ready-made systems. The good news for drug makers is that these offerings are being created based on previous designs and data utilized for original biologics drugs. The challenge biosimilar manufacturers face is knowing which delivery system is best for their drug and how quickly their partner can assist them in getting the offering to market. This is where having a trusted partner in the drug delivery device manufacturer space to guide them as they choose the appropriate system to deliver their drug is incredibly helpful.

How supportive is the regulatory landscape for research and development of biosimilars in India?

There is a growing interest in biosimilars among biopharmaceutical companies in India, and according to the recent Quintiles IMS report, "Outlook for Global Medicines through 2021," pharmerging markets such as India will continue to be driven by non-original products over the next several years. At the same time, there is also a shift toward regulatory bodies in India and elsewhere across the Asia Pacific region placing increased focus on quality standards and lower particle burden for injectable drug products. Greater regulatory scrutiny and quality standards are placing added demands on drug manufacturers, suppliers and contract service providers. Driven by concerns for patient safety, regulatory agencies in India and around the world are asking drug and packaging manufacturers to build quality into their products from the start to ensure consistent quality throughout a drug product's lifecycle.

What are the best practices followed by West for improving patient outcomes through integrated containment and delivery systems?

combination products, meaning the injectable drug is paired with a delivery system. As a result, pharmaceutical companies are paying closer attention to the design, function and efficacy of integrated delivery systems. This, coupled with a broader trend in the market toward patientcentric design and increased home-based administration, means that it is important for drug manufacturers to carefully consider the delivery system they select for their drug.

Drug manufacturers have often relied upon patient focus groups for insight into end user considerations for self-injection systems. However, the narrow focus group setting doesn't provide a full picture of how patients use injection systems in multiple environments: at home, work and other settings. Integrated drug delivery system development must be considered in the context of how a patient interacts with the system differently at each stage of their journey and in the various environments they encounter each day.

A best practice employed by West is to utilize human factors analysis, usability testing and engineering to provide a detailed understanding of patient behaviors, motivations and needs. By applying human factors principles and conducting extensive usability testing early in the design process, drug manufacturers and their delivery system partners like West can maximize the likelihood that that the self-injection system user interface is safe and effective for use by the intended users, uses and environments.

What are West's innovative solutions for injectable drug administration?

West has several innovative drug delivery system and packaging component technologies, including:
  • SmartDose platform - a wearable, subcutaneous injector with an integrated drug delivery system that incorporates human factors and usability testing to deliver a truly patient-centric approach to self-administration.
  • SelfDose patient-controlled injector - an off-the-shelf delivery system that is ergonomically designed for optimal patient administration.
  • Administration systems - including devices for reconstitution, transfer and delivery.
  • NovaPure components - high-quality components for higher-volume pre-filled delivery systems designed using Quality by Design (QbD) principles to reduce particulate and ensure consistency of delivery.
  • Daikyo Crystal Zenith cyclic olefin polymer - a high-performance alternative to glass and an integrated lifecycle solution for containment and delivery systems designed to help maintain drug safety, purity and efficacy from development through to commercialization.
How is West contributing to the biosimilars and generics market in India?

West works by the side of drug companies in India and around the world to improve the delivery of healthcare to patients. We know the complexity of these drugs and their need to be delivered through an integrated system that is safe, reliable and patient-centric. We also know that generic and biosimilar manufacturers feel immense pressure to file first, and we have a comprehensive portfolio of offerings to help them to get their products to market quickly.

A key part of our approach is a focus on quality. Regulators and drug manufacturers alike place significant emphasis on quality standards. No longer just an innovative suggestion, Quality by Design has become a non-negotiable aspect of drug delivery technology development. Applying a datadriven, design control process and QbD approach to the design and development of packaging components and delivery systems can help ensure a delivery system that consistently functions as expected.

What are the challenges that we need to address to realize the vision 2020 to reach USD 200 billion industry?

Providing better healthcare to its citizens and being a nation that attracts the most talented scientists and scholars are key components as India moves toward Vision 2020, and a burgeoning biosimilars market is one way to progress toward achieving the vision. But before touching on challenges, I think it is important to note that India has significant potential to become a leader in the biosimilars market. As discussed above, with many biologics poised to come off patent over the next several years, there is opportunity for biosimilar manufacturers to capitalize on market opportunities and bring more affordable medicines to the market.

In India, where biologics continue to be one of the fastest growing segments, there are a few considerations to keep top of mind. First, it will be important to keep quality built into the drug itself as well as the delivery system. Second, it will be important to choose drug delivery systems that are patient-centric. The therapy cannot be effective if the patient doesn't want to take the drug.

Which are the areas that West is currently working on? Could you update us on West's product pipeline?

West is continuing to focus on the trends we are seeing in the industry. One that we've talked about a lot here is quality, and that remains a top priority. Another is a move toward more self-administration. In India and around the world, care for many chronic conditions is moving out of the doctor's office and into the home environment.

Finally, an additional area of focus for West is on speed and flexibility in the supply chain. Once a medicine is manufactured, it's important to get it to market quickly without compromising quality or reliability. At West, we have the flexibility to respond quickly to customer needs. One example is our AccelTRATM Component Program that delivers packaging quality, speed and simplicity for generics customers, for whom it is so important to file quickly. The AccelTRA Program offers market-leading delvery times and a single next-generation formula for stoppers that help customers stay competitive.

How do you intend to steer the growth of West in the years to come?

To remain competitive, we plan to continue to grow our manufacturing capabilities for products. We will also keep collaborating with pharmaceutical companies in India as they bundle their products for regulatory approval. Last but certainly not least, we will make sure we continue to manufacture products that are innovative and designed with the patient in mind.