Finish as ‘First-to-File’ in Pharma Generics’ Launch Race - Part 1

Imagine a cross-country ultra marathon relay race lasting for several days. Usually, a relay race has one team player running at a time, handing over the baton to the next one. However, in our ultra relay race each competing team has multiple internal teams running each segment. Baton exchange is permitted only after all internal teams arrive at the end of the segment. Each competing team and their internal teams have their own support crews. The teams can change their players at any time. The competing team finishing first earns prestige and a huge cash prize. The teams coming second and beyond see diminishing cash prizes.?

I am not aware of any running race like the above. But Pharma product launches are similar to the above imaginary race, only far more complex. They last for years, not days. The competing teams (the companies) and their internal teams face unexpected hurdles like regulatory roadblocks, litigation, or technical setbacks.?

Having a pipeline of new drug launches is crucial for the success of Pharma companies. As products mature their margins shrink due to increased competition. Pharma companies aim for a healthy proportion of revenues from new launches to enhance their profitability and market positions. There are two types of pharma product companies: innovators and generics.?

Innovator companies develop new drugs from scratch, which typically takes about 10-12 years. They go through extensive research, clinical trials, and regulatory approval processes. Once approved, they get exclusivity to sell the product for about 12-15 years.

Generics drugs companies, on the other hand, develop versions of existing drugs after the patent expires. This process typically takes 2-3 years. The first generic company to get approval after patent expiry is called "first to file" and enjoys a 6-month exclusivity period. Naturally, the ‘ First-to-File’ privilege is coveted by every company.?

Not achieving the ‘ podium finish’ means lower ROI and longer payback of years of investments.

In this two part series, I shall focus on generics launches since they are far higher in number than completely innovative drugs. I shall outline the unique NPD process, describe the current practices, and challenges that pharma companies face while launching new generics. I shall then discuss how an advanced PSA can power the product launch projects.

The NPD launch process

Strategy development

A product strategy involves which therapies (e.g., oncology, neurology, cardiology) to focus on, choice between big (complex and expensive-to-develop) or small molecules (easier to develop, lower-priced), and identifying target markets (e.g., 50% US, 25% Europe, 25% Rest of World).

Molecule Selection

Business development teams evaluate molecules going off-patent on a future date. They assess which molecules align with company strategy. They conduct technical feasibility studies (skills, production capability, patent infringement risks). They analyse market size, potential revenue, and competition related to the short-listed molecules. They then propose a business case considering technical and commercial aspects. They estimate payback period and ROI. This phase ends with company management approving a molecule for market launch.

Product Development

R&D teams (e.g. formulation, analytical, clinical) work on developing the selected product.? They face challenges like procurement delays, experiment/sample analysis time, and cross-functional collaboration. Clinical trials and their documentation are critical here. Therefore, tight project management is crucial to meet timelines and beat the competition.

Registration

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Registering the new product regulatory authorities like FDA requires voluminous documentation. Any deficiencies or queries from authorities need to be addressed. The aim here for first-time-right submissions to minimise delays.

Launch preparation

To take full advantage of drug approval, companies begin manufacturing 6 to 9 months before expected approval date. In this, they risk the production cost incurred. Simultaneously they line up logistics and distribution networks. They develop marketing strategies and engage with all stakeholders in the healthcare industry.

Post launch

After the launch, companies monitor the product performance in the market. They assess revenues, market shares, profitability, and gather customer feedback etc. against the launch budgets.

Challenges in generics NPD projects

Generics NPD projects are fraught with technical, supply chain, regulatory challenges. Each of the above phases needs specialised human resources, equipment, and materials.?

As these projects meander through the above phases over two to three years, activities get missed, outcomes remain untested, delays happen and their ill-effects cascade. ?

Traditional methods of managing projects, human and equipment resources, inventory, and dossier preparation are standalone. They make the adobe hurdles more difficult to overcome.

The ‘first to file’ goal of launching pharma products is indeed daunting.?

Like so many cross-industry use cases I described previously, an advanced PSA’s NPD solution can be an answer to the needs of the pharma industry.

I shall discuss the challenges in generics NPD projects and how an advanced PSA can power you in your race to ‘First to File’ in the Part -2 of this series..

Kytes, powered by AI, is an advanced PSA that powers your ‘ first -to-file’ race. Kytes eliminates many hurdles, helps you deal with complex tasks like dossier preparation, and maintain control over your NPD project execution.

For more information on the above or a demo, please contact us at [email protected]