Like all biotech companies, MoGen faced uncertainty regarding new product creation as well as challenges involved with sustaining a pipeline of future products. Now a competitive threat of follow-on biologics or “biosimilars” began emerging. As drugs neared the end of their patent protection, competitors would produce similar drug as substitutes. Competitors could not produce the drug exactly, because they did not have access to the original manufacturer’s molecular clone or purification process. Thus, biosimilars required their own approval to ensure they performed as safely as the original drugs. For MoGen, this threat was particularly significant in Europe, where several patents were approaching expiration.