EMD Millipore: The Development
and Manufacturing of Biosimilars
Simon Boa from EMD Millipore participates in a Q&A about the
benefits and challenges of (as well as the demand for) biosimilars.
As biosimilars form roots in the U.S., many companies are eager to launch into this new
industry and form partnerships.
On October 22, EMD Millipore
joined the ranks, announcing
that the company entered into an
alliance with Turgut Ilaç, a leading
biosimilars company based in
Turkey. In the first phase of their
agreement, monoclonal antibody
biosimilars for non-small cell
lung carcinoma and rheumatoid
arthritis will be their focus.
Simon Boa, PhD, MBA, Director
of Commercial Development Provantage, E2E
Services at EMD Millipore, participated in a Q&A
about emerging biosimilar market trends and the
challenges that this industry faces.
Q: What are some of the challenges you have or
expect to face in the development of biosimilars?
Boa: The most obvious challenge is to develop
a molecule that is similar to the originator.
Unlike innovator molecules, biosimilars need
to be compared against an existing originator
molecule. Typically, you will assess many originator
parameters through multiple batches that were
manufactured at different times and possibly in
different facilities. This will help create the range
within which you must fall when developing the
biosimilar. Since some of these parameters influence
each other, the complexity of process development
quickly escalates as you try and refine it.
The other principal challenge is regulatory
acceptance. The European Medicines Agency
(EMA) has well-established guidance; however, the
guidelines of other agencies are still being refined.
In a global economy, we aim to help our clients
negotiate through this complexity so that they
have a process and resulting drug that is broadly
accepted for their key markets.
Q: How do you think the development of
biosimilars differ from the development of
Boa: For chemically-derived “small molecules,” the
creation of generics is much more straightforward
since the chemical structure will be identical; the
emphasis is on understanding and controlling the
impurities. For biosimilars, both the structure and
impurities need to be understood, as both can and
will vary. In particular, the upstream development—
when the cells are created and grown—is
particularly challenging; this is where the structural
changes principally occur. The downstream
purification process is slightly easier, where the
emphasis is on impurities.