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New Formulations Of Old Ingredients Do Not Qualify For SPCs

Abraxis’ attempt to obtain a UK SPC for its Abraxane formulation of the known active ingredient paclitaxel has been thwarted by the CJEU.
Intellectual Property Europe Cancer

Alvogen's Lotus Secures Deal With Fuji To Bolster Asia Presence

Alvogen’s Taiwanese subsidiary Lotus has confirmed a cross-investment partnership with Fuji that will strengthen the firms’ commercial platform in Japan and other key Asian pharmaceutical markets.

Japan Deals Companies

Advanz Ponders Photofrin Sale As It Weighs Deals in Europe

Advanz Pharma is considering slimming down its US operations as it searches for global product deals and company acquisitions in western Europe to restore sales growth.

Value-Added Medicines M & A Sales & Earnings
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Commercial Explore this Topic

Advanz Pharma Is Preparing For Growth With New Strategy, Team and Capital

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.


Business Strategies M & A

Dr Reddy's Increases API Operational Efficiency With Customer Service Portal

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”.

Manufacturing Generic Drugs

Launches And International Sales Propel Growth For Teligent Despite Bumpy Year

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.

Sales & Earnings Business Strategies

Manufacturing Roundup - 19 March 2019

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.

Companies Manufacturing

Aspen Outlines Four Priorities As Focus Shifts To Global Specialty

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.

Business Strategies Sales & Earnings

Eastern European Results Roundup: Grindeks, Alkaloid, Olainfarm, Podravka, Sopharma

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.

Europe Companies
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Policy & Regulation Explore this Topic

AAM Warns Over Weakening 180-Day Incentive

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.

Regulation Generic Drugs

France Adds Five Pegfilgrastims To Biosimilar Equivalence List

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.

Regulation France

Italy Makes Moves To Raise Biosimilar Use And Awareness

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.

Italy Biosimilars

FDA Must Do More To Counter Misinformation On Biosimilars

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.

Regulation Biosimilars

Industry Alliance Supports Commission On Environment

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.

Regulation Europe

Novitium’s Pyridostigmine Shows Six Appeal Of CGT Pathway

In granting its sixth approval for an ANDA with a Competitive Generic Therapy (CGT) designation, the FDA insists it is fostering competition in the US off-patent market.
Approvals Generic Drugs
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Latest From Generic Drugs

Advanz Pharma Is Preparing For Growth With New Strategy, Team and Capital

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.


Business Strategies M & A

Dr Reddy's Increases API Operational Efficiency With Customer Service Portal

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”.

Manufacturing Generic Drugs

Hikma Plans to Partner Away From Branded Generics Focus In MENA

With local competitors in the MENA region increasingly able to compete on branded generics, Jordan’s Hikma is shifting the focus of its local operation towards partnering for patent-protected products.
Middle East and Africa Business Strategies
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Latest From Biosimilars

France Adds Five Pegfilgrastims To Biosimilar Equivalence List

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.

Regulation France

Italy Makes Moves To Raise Biosimilar Use And Awareness

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.

Italy Biosimilars

FDA Must Do More To Counter Misinformation On Biosimilars

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.

Regulation Biosimilars
See All

Latest From Value-Added Medicines

Accord Agrees Leuprolide Deal as Part of Differentiation Strategy

Accord is furthering its push into added-value medicines by entering into a licensing agreement for Foresee’s injectable suspension leuprolide injectable.
Value-Added Medicines Deals

Celltrion’s Subcutaneous Infliximab Shows Promise

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.

Biosimilars Strategy

TLC Seeks A Second Opinion On Doxolipad

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.

Europe Regulation
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