The Drive for Best Practice in Biopharmaceutical Manufacturing - Key business considerations when developing biosimilar products virtually. - BioPharm International


The Drive for Best Practice in Biopharmaceutical Manufacturing
Key business considerations when developing biosimilar products virtually.

BioPharm International
Volume 25, Issue 3, pp. 60-64


Finox Biotech is organized as a "virtual" biotech. The company has no internal development or production capacities and in-sources these within a network of partners. The team consists of about 5.5 full-time equivalents. The company's operations are, therefore, fully focused on the identification, commissioning, leadership, and supervision of external partners. The selection of partners is highly crucial to the company's success.

With only a relatively small amount of business to propose, one may conclude that it is difficult to foster interest with qualified potential partners, small or large. However, given the appetite of contract developers and manufacturers for gaining a biosimilar track record, reality proves the opposite to be true. But care must be taken, because some contract organizations find it difficult to internalize the different needs of biosimilar development compared with new compound development. The latter is primarily about research (with long timelines and trial and error loops), but biosimilar projects are much more about straightforward development on short timelines and scarce budgets.

For small organizations such as Finox Biotech, it is important to find partners that match these focused structures. They may be small (or large) companies who have organized themselves into small entrepreneurial units with whom to interact. A large organization with steep or abyssal hierarchies and a crowd of people interfacing on common business issues would overburden the capacities of a small start-up. Furthermore, in a virtual development and supply setup, it is essential that the resulting network becomes a real entity. For biologics, "the process is the product," so in a virtual development and product supply chain, the implementation of this vision becomes even more crucial to turn out a sound product. A virtual company requires partners who fully understand the implication of this vision. All partners must also buy into the overall responsibility, as it is not feasible for a small core team to oversee and guide every detail in the interface between two external partners.


Biosimilar development is not about conducting breakthrough research. Rather, it is about hitting the ground running and pressing the fast-forward button by using existing technologies to ensure first-in-class market access. Swift execution also incorporates the need to accept that some options must be left aside so as not to slow the overall process.

Product development is complex; it involves many specialists and must address wide-ranging issues, so a big danger lies in inappropriate decision-making. Too often, a good head start is lost because managers are unable to agree on an idea that should be skipped to stay focused and in fast forward mode. Dragging along too many alternatives and slowing down the development process often results from one poor project manager being charged with full responsibility while others sit and watch the project branch-off down the wrong track.

At Finox Biotech, the project manager is neither in charge nor left alone. In fact, a broad management team takes responsibility for achieving overall development goals. This is all the more important given that a single project manager cannot usually cope with the multiple strategic issues that occur in biosimilar development.

The ever-evolving quality and regulatory landscapes need to be continuously integrated into product development strategy formulation and execution. The IP environment must also be followed closely with product development adapted accordingly. Attention must be paid to what is coming off patent but also, and perhaps more importantly, to what is going on patent, which is potentially one of the more damaging defensive

strategies of originator companies against biosimilar competitors. Last but not least, the cost of goods sold (COGS) will be one major enabler of competitiveness and the project manager alone will have difficulties in presenting a satisfying result if he alone is managing COGS.

Overall, during product development, there needs to be a spirit of execution that enables a high decision-making rhythm as well as a sense of maintaining focus on the essential attributes that the final product offering should present. One must not waste time and dissipate energy on a set of alternative opportunities.

Product development should be supported by constant confirmatory exchanges with regulatory authorities. Biosimilars are a nascent class of products, so authorities learn alongside companies developing products in this field. Accordingly, authorities' expectations evolve during product development and an agreement sought some time ago may not reflect the expectations in the future.

Be it FDA or EMA, both agencies provide supportive instruments for ensuring development progress, according to the respective guideline indications. Indeed, both agencies share the company's overall goals of bringing safe, efficient and affordable medicines to patients. However, sometimes the detailed understanding of what is required to achieve this overall goal may differ between the company and the agency. Finox Biotech's experience is that it is worth challenging agency requests. Sometimes, one might want to take an alternative route than what the agency proposed to achieve a certain goal. Our experience shows that if a different approach is scientifically justified, the agencies are open to negotiation. Sometimes it is worth saying "no" in order to achieve a more attractive, commonly agreed upon "yes" thereafter.

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