Biocon gets approval for generic Crestor in Europe

Hyderabad: Biopharmaceuticals firm Biocon Ltd on Monday said it has got approval to sell the generic equivalent of Astrazenaca Plc’s cholesterol-lowering pill Crestor in the European Union (EU).

The approval is for the 5 milligram (mg), 10 mg, 20 mg and 40 mg dosage forms of the drug.

Crestor, generically called rosuvastatin calcium, is Biocon’s first-ever generic formulation approval in a regulated market.

“(It) marks an important milestone in Biocon’s small molecules strategy of forward integration from APIs to finished dosages,” Biocon said in a statement.

“The approval for rosuvastatin calcium, through decentralized procedure, will open the doors for Biocon to over 15 European countries and will enable the company to address $1.2 billion opportunity, starting FY17,” the company said.

Biocon said it become the first generic company to receive a certificate of suitability (CEP) for rosuvastatin calcium active pharmaceutical ingredient from the European Directorate for the Quality of Medicines (EDQM). CEP certification indicates that an API is suitable for use in medicinal products in the EU.

“This is indeed a proud moment for Biocon’s small molecules business,” said Kiran Mazumdar-Shaw, Biocon chairperson and managing director.

“We plan to collaborate with regional partners in the near term to provide access to this affordable generic and thus help patients and governments to bring down their healthcare spends,” Majumdar-Shaw said.

Biocon said it aims to boost its generic formulations business with a pipeline of 20-25 filings over the next few years targeting regulated markets such as the US and the EU.

The company is building a new oral solid dosage formulations facility in Bengaluru to enable its expansion in the generics space.

Biocon said it had filed an initial set of marketing authorization applications in the EU and abbreviated new drug applications (ANDAs) in the US in FY15 in addition to working on dossiers to introduce these formulations in emerging markets where regulatory clearances are primarily based on approvals given by regulators in the US and the EU.

Analysts say Biocon, which sells APIs, the key substances that lend drugs their healing property to pharma firms abroad, is trying to move up the value chain to higher margin formulation or finished dosages business, as biosimilars, the company’s flagship products, are expected to take at least two-three years to start contributing meaningfully to the company.

“Generic Crestor is a small molecule, and there will be significant competition from established generic players, it needs to be seen how Biocon will play in this space,” said Afzaal Mohammed, pharma expert at Karvy Stock Broking Ltd.

Biocon is confident.

“In small molecules our strength is in statins and immuno-suppressants, we are one of the largest global supplier of these complex APIs, so we are starting with statin as our first generic product,” said a Biocon spokesperson.

Shares of Biocon Ltd gained 4.57% to ₹ 464.30 at 12pm on BSE, while the benchmark Sensex gained 2.29% to 23,512.91 points.