Armed with a new strategic vision under a new management team and with fresh financial firepower, Advanz Pharma is ready to start striking deals, chief executive Graeme Duncan explains.

Dr Reddy’s has strengthened operational efficiency for its generics API customers by launching a customer service portal that enables users to “manage the whole business process in real time”.

In 2018, product launches and growth in International sales enabled Teligent to post a group sales rise of almost a tenth to US$65.9 million, despite price erosion and serialization requirements impacting the business. Teligent expects its expanded US manufacturing facility in Buena, New Jersey, to be inspected by the FDA in the first half of 2019, with its first injectable to be launched from the site by the end of the year.

Several firms are looking to expand their manufacturing capabilities through acquisitions and investments; however a number of companies are suffering setbacks. Biocon gets hit with six ‘Form 483’ observations across two sites in India, as Jubilant, Pfizer’s Hospira and Andapharm are slapped with FDA warning letters.

Disposing of its Nutritionals business allows Aspen to fully focus on pharmaceuticals, while the firm is looking to drive organic growth with an emphasis on its Emerging Markets division, optimizing its complex manufacturing capabilities and seeking collaborations in territories where it “lacks sufficient critical mass”. These are among the measures Aspen has identified as it outlines four priorities for the firm, as the group shifts from being a regional generics company to a global specialty business.

Several Eastern European generics companies achieved sales growth in 2018. Looking ahead, Grindeks plans to strengthen its presence in Russia and other CIS countries, Alkaloid is set to continue investing in production facilities and technologies, while Olainfarm looks to upgrade its product dossiers.

Proposals as part of the latest US budget to amend provisions around the 180-day exclusivity incentive for generics could risk weakening the critical driver of competition, the AAM has warned.

Five pegfilgrastim biosimilars have been added to a newly-created group in France’s list of similar biologics, with Neulasta as the reference brand. At the same time, the country’s ANSM medicines agency has also added further biosimilars to the list against other already-listed biologic brands, and has also created new generic groups for three molecules in its répertoire of generic equivalents.

The use of biosimilars is growing in Italy, but the authorities want their market share to rise further and so the regulator has set up a dedicated webpage to explain the biosimilar concept more clearly to doctors and the general public and to help dispel any remaining doubts about their safety and efficacy. The aim is to increase awareness and use of biosimilars and rationalize state spending on biologic medicines.

More should be done by the FDA to counter misinformation perpetuated by originators over biosimilars, the AAM and its Biosimilars Council have urged in comments attached to a citizen petition lodged by Pfizer.

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Armed with a new strategic vision under a new management team and with fresh financial firepower, Advanz Pharma is ready to start striking deals, chief executive Graeme Duncan explains.

Dr Reddy’s has strengthened operational efficiency for its generics API customers by launching a customer service portal that enables users to “manage the whole business process in real time”.

Five pegfilgrastim biosimilars have been added to a newly-created group in France’s list of similar biologics, with Neulasta as the reference brand. At the same time, the country’s ANSM medicines agency has also added further biosimilars to the list against other already-listed biologic brands, and has also created new generic groups for three molecules in its répertoire of generic equivalents.

The use of biosimilars is growing in Italy, but the authorities want their market share to rise further and so the regulator has set up a dedicated webpage to explain the biosimilar concept more clearly to doctors and the general public and to help dispel any remaining doubts about their safety and efficacy. The aim is to increase awareness and use of biosimilars and rationalize state spending on biologic medicines.

More should be done by the FDA to counter misinformation perpetuated by originators over biosimilars, the AAM and its Biosimilars Council have urged in comments attached to a citizen petition lodged by Pfizer.

Data revealed by Korea’s Celltrion demonstrates that the firm’s subcutaneous infliximab is comparable to the intravenous formulation, with a study showing that auto-injection is a viable administrative method.

After the CHMP last month refused to recommend granting approval for TLC’s doxorubicin hybrid, the firm has asked the committee within the EMA to revisit its opinion.