Recent advances in synthetic drug manufacturing have introduced a new dynamic to the European regulatory system, with chemically synthesized polypeptide products using biological originator products as their reference medicine. Whereas biosimilars are subject to a dedicated regulatory framework in the EU, synthetically produced follow-on products are not eligible for assessment through this pathway, requiring approval via the traditional generic pathway under Article 10 (1), or via the hybrid pathway under Article 10 (3). This review presents an overview of recent developments in the field of synthetic peptides referencing biological originators in the EU. The use of different regulatory procedures can have potential implications for regulatory assessments, clinical practice and pharmacovigilance. As more complex synthetic products referencing recombinant originator products are expected in the coming years, this study promotes more transparency as well as global alignment about regulatory procedures for chemically synthesised products referencing biological originator products to ensure approval of safe and high-quality generics.

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BACKGROUND: An incisional hernia is a common complication of abdominal surgery.
OBJECTIVE: To evaluate the outcomes and complications of hybrid application of open and laparoscopic approaches in giant ventral hernia repair.
METHODS: Medical records of patients who underwent open, laparoscopic, or hybrid surgery for a giant ventral hernia from 2006 to 2013 were retrospectively reviewed. The hernia recurrence rate and intra- and postoperative complications were calculated and recorded.
RESULTS: Open, laparoscopic, and hybrid approaches were performed in 82, 94, and 132 patients, respectively. The mean hernia diameter was 13.11 ± 3.4 cm. The incidence of hernia recurrence in the hybrid procedure group was 1.3%, with a mean follow-up of 41 mo. This finding was significantly lower than that in the laparoscopic (12.3%) or open procedure groups (8.5%; P < 0.05). The incidence of intraoperative intestinal injury was 6.1%, 4.1%, and 1.5% in the open, laparoscopic, and hybrid procedures, respectively (hybrid vs open and laparoscopic procedures; P < 0.05). The proportion of postoperative intestinal fistula formation in the open, laparoscopic, and hybrid approach groups was 2.4%, 6.8%, and 3.3%, respectively (P > 0.05).
CONCLUSIONS: A hybrid application of open and laparoscopic approaches was more effective and safer for repairing a giant ventral hernia than a single open or laparoscopic procedure.